Global Project Manager Salary in Norwood, MA

The Role:Reporting to the Associate Director, E_Data (CSV) Quality, located at Moderna in Norwood, MA, the Manager of Digital Quality, applies established knowledge and experience in systems validation and lifecycle. The Manager should be familiar with global Health Authority Regulations including US FDA, ICH and guidelines (GAMP, Computer Systems Used in Clinical Investigations, etc.) and is responsible for the oversight, review, and approval of GCP/GLP/GVP-related computer system validation activities with a focus on quality support over GcLP internal validation activities of computerized systems/instruments/equipment, research computer systems vendor audits and internal system audits. The Manager will also partner with R&D to create a quality culture within Moderna, provide business support, process improvements and inspection support as needed. This position may interact with regulatory agencies and corporate partners during inspections and audits, and it will require travel for auditing vendors.Here's What You'll Do:Lead and co-lead internal and vendor computer system audits related to GCP/GLP/GVP systems including but not limited to pre/post audit meetings, agenda, partnering with key stakeholders, review of legal contracts and vendor/internal processes ensuring systems are developed, validated, managed, and controlled based on applicable regulations and guidelines.Manage audit-related observations and CAPAs.Work closely with the Digital Technology department, system owners and business owners to implement new systems/instruments/equipment effectively and efficiently, system upgrades, or system modifications.Participate in the change control program for modifications to qualified systems and/or implementation of new systems.Review and approve computerized system, GcLP laboratory instruments, and GcLP equipment-related documents and procedures.Support regulatory agency inspections as needed.Participate and actively engage in strategic initiatives which require CSV support.Provide support and input into the full CSV and SDLC program.Contribute to the continuing development of a quality culture at Moderna.Perform other tasks as assigned by the line manager.Here's What You'll Bring to the Table:BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience in the pharmaceutical/biotech industry with experience in the R&D Computer Systems Validation GCP/GLP/GVP environment.Demonstrated ability to work in a risk-based CSV environment following the associated regulatory expectations.Knowledge of Software Development Life Cycle (SDLC) principles including planning, analysis, design, development, testing, implementation, and maintenance is required.Experience and practical understanding of the development and validation of custom GAMP category 5 software, modules, interfaces, and reports is desired.Experience and proficiency with CSV audit for Research computerized systems is desired.Practical understanding of GAMP and ERES standards and guidance.Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations (understanding of regulatory guidelines for other countries a plus), CFR 21 Part 11.Expertise with business office applications, word processing and spreadsheets.Demonstrated knowledge and/or prior experience in Quality Assurance and oversight of GVP systems such as Argus and Signal Detection.Outstanding communication skills (verbal and written)Ability to manage multiple projects in a fast-paced environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.Relies on experience and judgment to plan and accomplish goals.Excellent organizational skills and keen attention to detail.Travel Requirements (as a %)Travel up to 30% based on business needs.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-LG1-

The Role:The Sr. Manager, Global Regulatory CMC will be support regulatory CMC activities for one or more programs. The Sr. Manager will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy. The Sr. Manager will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients and will be based at the Norwood, MA site.Here's What You'll Do:Support development of CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risksProvide guidance for regulatory CMC aspects of product development projectsReview documents for submission-readiness, to ensure that all submissions conform to health authority guidelinesContribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissionsSupport develop regulatory processes and procedures to support CMC components of regulatory submissionsSupport the creation and maintenance of CMC submission templatesProvides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controlsProvides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programsHere's What You'll Bring to the Table:Minimum QualificationsBA/BS degree in a scientific/engineering discipline6+ years of experience in the Pharmaceutical industryKnowledge of current US and EU regulations and cGMPExperience with CTD format and content regulatory filingsExceptional written and oral communicationPreferred QualificationsBS or MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable8+ years of experience in regulatory in the pharmaceutical/biotech industry4+ years of experience in Regulatory CMC is desirableModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-LG1-

GENERAL SUMMARY/ OVERVIEW STATEMENT:Brigham and Women's Hospital is dedicated to:• serving the needs of our local and global community• providing the highest quality health care to patients and their families• expanding the boundaries of medicine through research• educating the next generation of health care professional.Brigham and Women's Hospital is committed to putting every Patient First. Every employee plays a role in providing a positive impact on patients and the care they receive at Brigham and Women's Hospital. Your work will be distinguished by the delivery of high-quality and safe patient care, respect, and dignity in all interactions with patients, families, and colleagues and by customer service excellence.All employees are expected to embrace this commitment and demonstrate behavioral competencies in the following areas:People: Focus on serving the community through collaboration and respectSelf-Management: Accountability, professionalism and commitment to growth and developmentOrganization: A commitment to quality, service, and exceptional performanceMeeting these expectations is key to the success of your department and the organization.PRINCIPAL DUTIES AND RESPONSIBILITIES:Perform duties under moderate supervision with intermediate to advanced proficiency in administrative skills.Act as a super user for scheduling, registration, and billing systems. Provide training and assistance to others in these areas.May perform more complex or specialized functions (i.e., surgical scheduling) at highest competency level.Utilize knowledge of HMO's, managed care, and other third-party insurers, and troubleshoots insurance issues as appropriate.Assist with training and orienting staff as needed.All staff must adhere to the Where We Work Policies and Procedures.On-site presence will be required for all work, routine staff meetings and trainingsProvide cross coverage as needed.Assist with special projects as directed.Follow HIPAA guidelines for the management of patient privacy and confidentiality.Other duties, as assigned.Qualifications Qualifications• High school diploma or GED required; post-high school education preferred.• Minimum one year of applicable work experience required. Primary Care experience preferred.• Additional training in office systems preferred. SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: Technical skills required:• Knowledge of practice operations and standards.• Understanding of procedures including filing, copying, scanning, printing, and faxing.Phone skills:• Ability to use phone system (answer and screen calls, put on hold), answer routine questions, and give routine information.Verbal skills:• Ability to interpret information as appropriate, answer routine questions in the most professional manner, and communicate in a professional, courteous, clear, and concise manner.Organization Skills:• Ability to manage work processes in a neat and orderly way and to sort and alphabetize.• Ability to manage multiple tasks effectively, follow established protocols, and work within systems.Critical Thinking Skills:• Ability to prioritize urgency of incoming calls and direct to the appropriate resource, while following established practice protocols.Writing Skills:• Ability to correspond and communicate with others clearly and effectively in writing (via e-mail, memo, or interoffice note) and to take complete and accurate messages.System Skills:• Ability to type and enter data at an entry level. Entry level understanding of applicable systems.• Understanding of the appropriate use and importance of related forms.• Basic understanding and use of medical terminology.• Basic comprehension of insurance types and referral process.• Basic comprehension of registration and fiscal information.• Knowledgeable and compliant with all hospital, State, and Federal requirements (where applicable to job performance), including policy and procedures with The Joint Commission and HIPAA.WORKING CONDITIONS: Onsite location:Hospital based ambulatory practice. Normal patient environments where there are some exposures to communicable diseases, unpleasant odors, needle, and blood products.HOSPITAL WIDE RESPONSIBILITIES: Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH/Partners; follows safe practices required for the position; complies with appropriate BWH and Partners policies and procedures; fulfills any training required by BWH and/or Partners, as appropriate; brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff.BWH Behavioral Competencies 1. People: Focus on serving the community through collaboration and respectInclusiveness: Maintain an environment where individuals value and respect differences in all situations. Stand firm against intolerance and bias to create a welcoming environment and respect all individuals regardless of race, gender identity, ethnicity, language, sexual orientation, age, physical or mental ability, religion, socio-economic status, or national origin.• Work effectively with others who have diverse perspectives, talents, roles, backgrounds and/or styles• Contribute to a positive team environment where differences are respected, supported and are free from stereotyping and offensive comments• Be professional when approached about behaviors that might be perceived as disrespectfulOpen Communication: The ability to effectively articulate and receive information in a clear, concise and timely manner.• Practice active listening skills• Foster and maintain an environment that respects open dialogue, differences of opinion, as well as diverse communication styles• Ensure that information is shared in a clear, accurate, and timely manner using the appropriate communication method for your audience• Express oneself clearly and professionally in your verbal, non-verbal, written, and electronic communicationBuilding Collaborative Relationships: Identifying opportunities and taking action to build relationships between one's area and other areas, teams, departments, units, or organizations to help achieve organizational goals.• Take initiative to support others and build productive relationships that will lead to a cohesive workplace• Interact effectively with other team members, departments, and customers to accomplish organizational goals.Organizational Awareness: Understand how one's own work affects the organization as a whole and demonstrate a commitment to the organizational goals.• Support and respect BWH's mission, vision, values, and history• Understand and recognize how your individual role and department impacts the organization.2. Self-Management: Accountability, professionalism and commitment to growth and developmentEmbracing Change: Demonstrate adaptability and openness to organizational changes needed to improve effectiveness and goals.• Support and positively participate in organizational and/or job specific changes• Initiate appropriate action when change is needed• Be flexible and open to new ideas• Adapt to shifting priorities.Learning Oriented: Predisposed to pursue learning opportunities even outside own comfort zone, one stays abreast of new tools and methods, rising to add value and build challenge in current assignments.• Demonstrate openness to learning from successes and failures• Recognize and participate in learning opportunities• Seek and share best practices.Professionalism: Practice respect for self and others; and adhere to BWH standards, policies, and procedures always.• Adhere to BWH's Code of Conduct, Guide to Ethical Standards, policies, and procedures• Align behavior with the organizational mission and values• Practice respect in accordance with the BWH standards• Demonstrate responsibility, reliability, and trustworthiness3. Organization: A commitment to quality, service, and exceptional performanceQuality and Safety Focus: Responsible for meeting standards of performance or outcomes in a safe manner while avoiding risks.• Align job performance with quality and safety standards (e.g., The Joint Commission, BWH and department specific standards)• Adhere to established policies and procedures• Take action to prevent errors• Identify and report adverse events, errors, and incidents.Efficiency and Performance Improvement: Systematic approach to improve performance by eliminating waste, non-value-added activities, and variability in processes.• Participate in process and performance improvement by identifying, analyzing, and enhancing existing processes to achieve better outcomes• Maximize available resources to achieve performance measures; reduce waste, rework, and work-arounds consistent with one's role.Problem Solving: Able to gather appropriate data and diagnose the cause of the problem before taking action; and if necessary, develop alternative courses of action.• Recognize actual and potential problems and take appropriate action towards a solution• Offer assistance, as needed, when a potential problem situation is observed• Use good judgment to keep manager informed of problems or issues, following department practice.Service Excellence: Focusing one's efforts towards anticipating, meeting, and exceeding the expressed and unexpressed needs or expectations of internal and external customers.• Apply service standards consistently to present a positive image of BWH to colleagues, health providers, patients, families, and visitors:• Engage with positive greetings and active listening• Empathize by expressing understanding• Educate throughout the information exchange• Enlist thoughts and ideas from others.4. General/Administrative Support:Information Gathering: Identify and seek information needed to clarify a situation. Ask questions to discover the facts.• Identify specific information needed to clarify a situation or to make a decision.• Probe skillfully to get at the facts.EEO Statement Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Apply now for the position of P58 NAM InVitro Commercial Project Manager to champion the corresponding business processes and endorsing the one global template. This is a hybrid role that can been performed in either the Malvern, PA or Walpole, MA location. Your role: You will plan, organize and execute data preparation activities for P58 roll out. You will be an active part in collecting requirements from all finance and operations teams during the scoping phase. You will manage project workstreams and develop escalation/reporting mechanisms. You will create and maintain detailed project plans for the area of responsibility. You will guarantee deliverables on time and agreed quality, report status. You will become an expert of the current processes of countries in scope. You will provide guidance to the countries and transfer know-how about the new template. You will represent the needs of the countries during all deployment phases. You will perform and facilitate data cleansing. You will verify and follow-up on data quality for migration. You will provide support as the data- and process expert in testing and during the cutover hyper care phase. You will support the key user environment in the wave countries. You will organize change impact identification throughout the roll out deployment phases. You will conduct knowledge transfer sessions and trainings for local scope, where necessary. You will provide support with testing of the local design during user acceptance testing Your expertise: Established knowledge and experience for the respective area of operation. Affinity to IT (dedicated SAP skills), processes, numbers, and analysis. Superior facilitation and presentation skills. Superior interpersonal skills and strong team player with interest working across zones/ borders and cultures expected. Experience leading change management efforts. Project management experience. Ability to influence and lead large teams for operational success. Commitment to project manage SAP P58 from preparation to a successful roll out The requirements: Bachelor's degree or equivalent experience required. High degree of project ownership and adherence to challenging deadlines. Excellent change management skills. Leadership in a cross functional/country environment. Expert knowledge on SAP P40/P41 3-5 years of OTC, and InVitro experience highly preferred. Demonstrated experience with SAP and Financial Systems. Willing to travel up to 20%. To find out more about the specific business, have a look at Siemens Healthineers Laboratory Diagnostics Who we are: We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://jobs.siemens-healthineers.com/careers Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site . "Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations." As an equal opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities. To all recruitment agencies: Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated. #LI-DC1 Equal Employment Opportunity StatementSiemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Reasonable AccommodationsIf you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accomodation for disablity form If you're unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367. Please note our AskHR representatives do not have visibility of application or interview status. EEO is the LawApplicants and employees are protected under Federal law from discrimination. To learn more, Click here .Pay Transparency Non-Discrimination ProvisionSiemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .California Privacy NoticeCalifornia residents have the right to receive additional notices about their personal information. To learn more, click here .

Director of Strategy for Point of Care Diagnostics Position Overview POC Diagnostics is in a growing category that is supporting, at a global scale, the decentralization of healthcare. More than ever, having a clear understanding of the market dynamics, customer and patient needs are critical to making timely decisions. Future success will be having the keen ability to extract the relevant insights, to inform a global strategy that combines upstream and downstream, partnerships, organic/inorganic development that positions us for success today and market leading in the future. Key Responsibilities Reporting to the global Head of Strategy & Portfolio Management, you will play a key role in advancing strategic topics for the business and ensure successful strategy execution You will interface with senior leadership within POC Diagnostics to understand and help shape strategic priorities, translate priorities into projects and metrics Lead team in defining market and innovation opportunities, predicting strategic competitive plays and marketing position, as well as creating strategic growth plans and a robust product roadmap in close alignment with the Leadership Team Lead the identification of new business models to drive growth opportunities (new markets, new channels, regional opportunities, tech uses, etc.) outside and within the existing portfolio You will scope, plan, and execute strategic projects targeting a range of key growth areas for the POC Diagnostics business. Projects could include geographic focus, profitability, or new technology applications. Key Success Factors Keen ability to articulate the market insights and strategy to position POC for future growth Be well versed in overall life sciences challenges and technology trends and have significant in-depth knowledge and experience in translating trends into successful operational strategies. You have experience in defining and implementing cross-functional strategic projects in global businesses as responsible project and/or program manager Proven track record in performing well in a fast-paced environment and crafting compelling positioning You are result oriented, you have grit, and you know how to overcome challenges to bring projects to successful conclusion You have a strong understanding of business processes across functions, how targets can be broken down into metrics, and how the pieces come together to ensure business success You know how to effectively communicate with a broad array of stakeholders You have strong visual presentation skills, particularly in Excel and PowerPoint and can efficiently use these tools to analyze and communicate business situations and opportunities Required Experience and Skills Bachelor's degree or equivalent experience in a technical field, business, or finance MBA or other advanced science / engineering degree strongly preferred Minimum of 10 years' relevant experience Minimum of 5 years' experience in the IVD (preferred), medical device, or life science fields Minimum of 4 years' experience in strategy consulting or corporate strategy You must have strong interpersonal and communication skills and the ability to create high impact communication materials You must have the capability to simultaneously lead and manage multiple high complexity projects Siemens offers a variety of health and wellness benefits to employees. Details regarding our benefits can be found here: https://www.benefitsquickstart.com/siemens/index.html . The pay range for this position is $139,362- $191,449 and the annual incentive target is 15% of the base salary. The actual wage offered may be lower or higher depending on budget and candidate experience, knowledge, skills, qualifications and premium geographic location. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on https://www.siemens-healthineers.com/en-us/careers . If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers . If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about . "Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations." Equal Employment Opportunity StatementSiemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.EEO is the LawApplicants and employees are protected under Federal law from discrimination. To learn more, Click here .Pay Transparency Non-Discrimination ProvisionSiemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .California Privacy NoticeCalifornia residents have the right to receive additional notices about their personal information. To learn more, click here .

The RoleIn this role, you will Reporting to the Senior Director, Capital Projects and Project Controls, the Director - Project Controls will be responsible for establishing and implementing project controls methodologies across the company including Front End project execution strategy development, estimating, scheduling, cost control, project buyout and logistics for all Moderna Capital Projects Worldwide.Here's What You'll DoThe Director - Project Controls will be jointly responsible with the Capital Projects Team for managing Moderna's annual spend in Capital, Construction and Engineering across all global functions in the organization. The role will ensure the projects are planned strategically, sequenced, budgeted and executed in an orderly compliant manner, ensuring that value from allocated funds are maximized. This includes implementing and managing the following key activities:Capital Planning:Collaborate with finance, operations and other internal stake holder to develop long range plansEstablish and implement means and methods to ensure reliable and accurate quarterly and annual forecasting of cashflowProject Execution StrategyEstablishing Project execution strategy, timeline and budget risk assessment, development of project buyout strategy and setting up project support teamPortfolio ManagementEstablish and implement means and methods to ensure reliable and accurate reporting on portfolio and project statusPartner with Project Managers to provide necessary levels of visibility to management's attentionEstimating & Benchmarking :Establish and implement estimating and benchmarking means and methodsPrepare initial estimates for mission critical projectsPartner with project management teams to ensure accurate estimateReview estimates prior to funding approvals to ensure accuracyScheduling & Progress MeasurementEstablish and implement scheduling and progress measurement means and methodsPrepare initial schedules for mission critical projectsPartner with project management teams to ensure accurate schedulesReview schedules prior to funding approvals to ensure accuracyCost Management:Establish and implement means and methods for project Cost ManagementEnsure timely review of project progress, invoice management and paymentEstablish and implement means and methods to ensure proper change and vendor managementContract Management:Partner with sourcing and project management to ensure appropriate contract types and execution strategies are deployedPartner with sourcing and project management to establish means and methods to prepare and review RFP templates, bids and ProposalFinancial and Schedule Risk Management:Establish and implement means and methods to develop and track, and mitigate cost and schedule risksAdditional duties as may be assigned from time to timeTeam ManagementAssist in accomplishing department objectives by managing both FTE& contract staff; planning and evaluating department activitiesAssist in maintaining staff by recruiting, selecting, orienting, and training FTE & contract support personnelAssist in accomplishing staff results by communicating job expectations; planning, monitoring, and appraising job results to FTE & contract support personnel.Coaches, counsels, and disciplines both FTE's and contract support personnelDevelops, coordinates, and enforces departmental systems, policies, procedures, and productivity standards.Provide Oversight of accuracy, quality control and cadence of project controls cost deliverables by FTE's and contract support personnelHere's What You'll Need (Minimum Qualifications)10-15 years of experience in a delivery of Capital, Construction and Engineering with at least 5 years specifically in the biopharmaceutical industry.10+ years of management experience in the areas of Project Controls or Capita Project execution around multiple geographiesBachelor's degree required. BA/BS in a Technical discipline desired; Master's degree (MBA, MS) preferred.Proficient-level skills in the following key competencies/skills: communications, project management, relationship management, estimating, scheduling, financial acumen, cost and financial management, aptitude for technology, results-focus, professionalism, and success in a matrixed environment.A proven track record of project delivery on fast track, highly technical projectsA proven track record of supporting a complex major capital programAbility to work in a highly metric-driven environment.A deep desire to be a key part of building a world-class Engineering function.Ability to lead through service, recommend execution strategies, and deliver business results.Strong collaboration and communications skills required to address and resolve issues in a matrixed environment and with the Finance function.Excellent negotiation, organizational, interpersonal and problem-solving skills Demonstrates strategic enterprise thinking, finding innovative ways to deliver results, and build trustMust possess outstanding communication, analytical, and problem-solving skills and the ability to work with enterprise-wide information systemsAbility to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor. Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.Ability to make effective oral presentations and work as part of a team.Here's What You'll Bring to the Table (Preferred Qualifications)Bachelor's degree required. BA/BS in a Technical discipline desired; Master's degree (MBA, MS) preferred.Deep understanding of Capital Project Controls - both Cost and Schedule elements, and associated elements of cost estimating, benchmarking, capturing actuals, monthly and annual forecasting, and tools such as SAP, Primavera P6, Microsoft Project, Oracle Unifier, Procore, Advanced Excel, Smartsheet and other Project Management/Cost Management tools.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The Role:The Principal Engineer for DP Filling Equipment will report to the Director of DP Process Engineering, serving as the subject matter expert (SME) for the Filling and closing Drug Product Manufacturing Equipment at Moderna. The incumbent will lead DP primary filling, containment and sterile operations engineering discipline for Capital Projects throughout Moderna's global footprint for both Clinical and Commercial supply operations.The role also involves providing guidance to existing manufacturing facilities, including contract manufacturing sites. The ideal candidate should possess knowledge of regulatory and performance requirements for process equipment used in the sterile filling and closing of pharmaceutical drug products.The Filling Equipment Engineer will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle, leading projects in the Fill and Finish Engineering discipline. This role requires the ability to manage multiple contractors and a portfolio of technical projects simultaneously.This role is based in Norwood, MA and reports to the Director of DP Process Engineering. Travel to support global manufacturing expansion could be up to 30% at critical project phases.Here's What You'll Do:Develop specifications for filling and closing equipment.Lead Front End Planning (FEP) activities for the filling and closing equipment scope on capital projects and programs.Contribute to/perform equipment vendor selection and assessments.Provide input to user requirements, design specifications, process parameters, and FMEA assessments.Own filling and closing best practices and functional standards that enable global standardization of process, equipment, and systems.Translate the business needs of the company into engineering solutions.Serve as a Subject Matter Expert in primary packaging.Independently execute, and direct others in the execution of, the design of processes and equipment.Identify new technologies for filling and closing primary packaging equipment.Drive results by owning and completing capital projects.Participate in all phases of engineering projects related to process equipment.Troubleshoot equipment to determine root cause of failure modes.Drive development of Engineering Turnover Packages.Here's What You'll Bring to the Table:A Bachelor's degree in Electrical, Mechanical, or relevant engineering disciplineMinimum of 10 years experience as an EngineerMinimum 10 years of experience in a GMP environmentA technical and regulatory background in DP filling and closing equipment in pharmaceutical industry.Experience in large capital/expansion programs with direct design responsibilityExperience with a Thermoforming, Heat Sealing, Plunger Insertion Side Load and Top Load Cartoning, Flexible Packaging Line Design, Vision Inspection Systems, Serialization and on-line barcode printing and verification and coding,Working knowledge of Aseptic Filling, Freeze Drying, Automatic Inspection and Clinical Packaging Operations would be preferred.Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required.Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions for complex problems. Familiarity with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor. Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -

The RoleModerna is seeking an Operations Manager of Drug Substance Manufacturing. This position will have oversight of the drug substance manufacturing operation. This role is accountable for the leadership, expansion and support of manufacturing business systems and production activities. The individual in this role will be a member of a cohesive team responsible for commercial/late-stage manufacturing of cGMP mRNA-based medicines. They will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System respecting global regulatory expectations. They will play a vital role in the continuing operations and maturation of our Norwood, MA facility by mentoring, coaching staff and improving our operations. This role will be part of the hiring, training, development and retaining a high-performing, manufacturing team that is capable of meeting manufacturing timelines.Here's What You'll DoEnsure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture and deliver on time to the clinic.Participate in the hiring, training, development, retention, and performance of staff for the leadership and execution of manufacturing operations.Develop batch records, SOPs and training materials for the Norwood Facility.Closely partner with QA peers for rapid disposition of mRNA medicines.Develop comprehensive operating plans and monitors the achievement of business and financial goals.Ability to manage multiple projects in a fast-paced environment.Ability to effectively collaborate effectively in a dynamic, cross-functional matrixed environment. Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement.Here's What You'll Need (Minimum Qualifications)Education: BS in Engineering or Science related major. Experience: 8 Years+ manufacturing experienceDemonstrated aptitude and understanding of GxP regulations (GMP, GLP, GCP, GVP or other applicable standards)Here's What You'll Bring to the Table (Preferred Qualifications)Proven people management skills.Leadership and project management abilities. Experience in a highly regulated industry, pharmaceutical, or related field.Problem solving and conflict resolution skills. Fluency in digital systems, including SAP.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) -