Software 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:Moderna is seeking a Manager, Sample Management for the Clinical Biomarker Laboratory to serve as a point of contact to support logistical aspect of clinical specimen testing activities across multiple clinical projects. This position reports to the Associate Director of Lab Operations, part of Moderna's Clinical Biomarkers group.Here's What You'll Do:Lead and participate in bio-specimen accessioning and ordering with our internal groupEstablish robust procedures to ensure shipment and tracking of biospecimen shipment through LIMS and specimen storage and preparation for all biomarker groupsEnsure tracking, delivery and tracking of biospecimen shipment through LIMSManage the specimen storage at the appropriate temperature and location in BiostoragePrepare specimen for technical staff for testing according to schedule and testing plans for the dayRecommendations for the implementation of strategic lab operation objectivesSupport the Lab manager with the implementation of new technical resources to improve on clinical specimen storage through LIMS (RFID system)Lead implementation of new automated platforms and their integration into the Lab operationsManage compliance to regulations and SOPsManage LIMS access for specimen accessioningSupport the implementation of strategic lab operation objectivesMaintain compliance to regulations and SOPsScheduling laboratory and equipment time for staffParticipate to the Laboratory workflow daily, including quality control on instruments, schedule maintenance with vendors upon needsActing as a liaison between leadership staff and key stakeholdersEnsuring that all team members have been trained to use laboratory equipment, software, and supplies safely and efficientlyMaintain clinical biomarker laboratory SOPs directoryActively participate in the cleansing and sanitizing of the lab according to EHS policies and Laboratory SOPsSpecific duties may change depending on the Laboratory growth and type of new instruments and personnel joining the team along the timeOccasionally the job may require overtime work or weekend shift as neededHere's What You'll Bring to the Table:Bachelor's degree in a scientific discipline is requiredMinimum 5 years of relevant sample management experience in CRO, biomedical institution, pharmaceuticalExperience in lab management (LIMS) and clinical specimen management are needed.Ability to oversee multiple aspects of the operations.Previous experience in working in CLIA, GLP or diagnostics regulated laboratory is preferredAttention to detail, organizational ability, judgement, and excellent communication skillModerna 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-MM1-

The RoleIn this role, you will report to and work closely with the Director, Digital Quality to design, deploy and manage our expanding portfolio of digital quality management systems that support Quality and batch release processes. This role will help shape and deliver the long-term strategic vision for the Quality QMS Digital roadmap. This opportunity is unique in the pace and speed we expect and achieve.Who You Are:You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. A master integrator gifted in bringing together people, concepts, and business goals with best-in-class execution. You thrive in a fast-paced environment and are comfortable rolling up your sleeves - if a process doesn't exist yet, you define it. You collaborate well amongst a team of expert peers.Here's What You'll DoDrive the execution of complex projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines through a blend of project management, technology, and business process expertise.Execute on our Digital Quality strategy with clear communication, prioritization, and escalation, both within Digital Quality and other cross functional teamsMentor a team of internal and external business analysts and software engineers designing, implementing, and maintaining our electronic quality management system, Veeva QualityPartner with digital stakeholders to ensure successful planning and integration of key systems into the quality management system while looking out for automation capabilities, and any artificial intelligence initiatives.Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.Support the Digital Quality Leadership Team by managing action plans and project plans to deliver short-, mid-, and long-term quality goals.Apply an operational excellence mindset to help Identify, devise, and recommend new opportunities to optimize current processes.Define and deliver a consistent systems governance methodology across applications with clear roles and responsibilities established throughout the system lifecycle: Implementation, Enhancement, and SupportEnsure GxP compliance is built into the design, delivery, and maintenance of all systems.Maintain inspection readiness through adherence to internal quality policies, procedures, and training.Participate in internal and external audits as digital quality expert for portfolio of processes.Hit the ground running immediately and work closely with various stakeholders in Quality to enable sustainable commercial operations.Here's What You'll Need (Minimum Qualifications)Bachelor's degree in science, technology, or another relevant academic discipline8-10 years of experience designing implementing and maintaining electronic quality management systems to support compliance processes in a regulated biotech or Pharma company.Experience with GAMP and GxP compliance regulationsHere's What You'll Bring to the Table (Preferred Qualifications)Strong understanding of batch release, quality management workflows, and related processesDemonstrated experience defining, scoping, and managing technology initiatives; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.Proficient in relevant project management software: Smartsheet, Excel, PowerPoint, Word, OneNote, MS Teams, etc. in addition to general knowledge with shared work environmentsPeople-orientedExtremely organized.Creative/innovative/problem solver that actively drives progress.Passion for people management and development in matrix teamsOutstanding communication, presentation, and writing skills and ability to tailor messaging to audience.Ability to manage multiple projects in a fast-paced environment.Ability to effectively collaborate in a dynamic, cross-functional matrix environment.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) #LI-KG1-

The Role:Moderna is expanding our footprint to further our mission of delivering the greatest possible impact to people through mRNA medicines! Our Norwood, Massachusetts's technology hub focuses on software product development for our Research, Clinical, and Manufacturing products and platforms. We are looking to hire experienced Application Development Leads who bring strong technical expertise, a product mindset that embodies the unique Moderna Mindsets, and passion to change the future of medicine. In this role, you will work on exciting, cutting-edge technology initiatives/products from the ground up to empower our technology roadmap across the organization, with the ultimate goal of transforming patients' lives.Here's What You'll Do:Work closely with a team of application developers, product managers, and validation specialists to deliver innovative solutions for our Clinical Biomarker LabLead regular checkpoints with staff and contracted developers, including code reviews and daily standupsResponsibly lead the overall technical design strategy and details to deliver against customer needsManage the process of product delivery end to end, and team's deliverables whether that's development of new code, configuration of existing functionality, or deprecating code Partners with product managers to deeply understand customer needs and creatively design, build, and deliver solutionsDemonstrate strong understanding of the business and customer value of software productsDiagnose and identify the root cause of software and logic problemsHere's What You'll Need (Minimum Qualifications):Bachelor's degree in computer science, engineering, business or a related field10+ years of experience in product-oriented application development5+ years of management experience overseeing engineers/developersExtensive developer experience with LabVantage LIMS (5 years)Broad exposure to digital lab connectivity and orchestration platform (e.g, Scitara or others), low-code platform-based workflow management tools (e.g., Appian or others), and lab data collectionWorking knowledge of biomarker assays and software for immunogenicity, flow cytometry and next gene sequencingWorking experience with AWS technology, including S3, redshift, and BoomiExperience documenting technical systems and design specificationsExperience with Software Development Life Cycles in a regulated environmentHere's What You'll Bring to the Table (Preferred Qualifications):Masters' degree in computer science, engineering, business, or other related technology disciplineExperience coordinating development projects with mixed teams of in-house developers and contracted service providersExperience communicating with application users to understand and collect their requirements and requestsExperience working in life sciences, pharma/biotech, or high-tech industries with a preference for experience in clinical biomarkers labs or clinical research organizationsExperience working in a regulated GxP environmentExperience working in a matrixed organizationA desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and CollaborativeModerna 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) -

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 .

The RoleIn this role, you will responsible for overseeing the successful introduction of new assets into the organization's portfolio. This role involves planning, coordinating, and managing all aspects of asset induction from initial assessment to final integration into existing systems and processes. The Project Manager will ensure that all assets are received, documented, and deployed in accordance with company policies and regulatory requirements.Here's What You'll DoProject Planning and Coordination:Develop comprehensive project plans that cover all stages of asset induction.Coordinate with various departments, including procurement, finance, IT, and operations, to ensure seamless integration of new assets.Schedule and lead project meetings to track progress and address any issues.Asset Assessment and Documentation:Conduct initial assessments to determine the suitability of assets for organizational needs.Ensure that all asset-related documentation is complete, accurate, and stored appropriately.Oversee the creation of asset records in the asset management system.Compliance and Standards:Ensure that asset induction processes comply with relevant laws, regulations, and industry standards.Develop and implement policies and procedures for asset induction.Coordinate with compliance teams to address any regulatory concerns.Stakeholder Management:Communicate effectively with stakeholders at all levels to keep them informed of project status.Work with suppliers and manufacturers to resolve any issues related to asset specifications or delivery.Build and maintain relationships with external partners and vendors.Budget and Cost Management:Monitor project expenses to ensure costs remain within budgetary constraints.Risk Management:Identify potential risks associated with asset induction and develop mitigation strategies.Monitor risk factors throughout the project lifecycle and adjust plans as necessary.Quality Assurance:Ensure that all assets meet quality standards and fit-for-purpose criteria before acceptance.Implement quality control processes during the induction phase.Training and Support:Provide training and support to staff on new assets and related processes.Develop user guides and documentation for ongoing asset management.Reporting:Generate regular reports on asset induction status, performance metrics, and milestones.Provide insights and recommendations to senior management based on project outcomes.Here's What You'll Bring to the TableBachelor's degree in Business Administration, Engineering, Asset Management, or a related field.Project management certification (e.g., PMP, PRINCE2) is highly desirable.Proven experience in project management, preferably in asset management or related areas.Strong organizational skills with the ability to manage multiple projects simultaneously.Excellent communication, negotiation, and stakeholder management skills.Proficiency in project management software and asset management systems.Knowledge of compliance and regulatory standards in the industry.Ability to work independently and make decisions under pressure.Work Environment: The role typically operates in an office environment but may require visits to various sites for asset assessment and integration. Some travel may be required.Additional duties as may be assigned from time to timeA 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) -

Senior Project Controls ManagerUS-MA-NorwoodJob ID: 2024-7232Type: Regular Full-Time# of Openings: 1Category: Cost Management/EstimatingCumming GroupOverviewAt Cumming Group, you will work on some of the world's most exciting projects in a dynamic environment where your success is measured by the impact you make. We are one of the fastest-growing project and cost management consultancies in the United States, as reflected in our top 20 ranking in ENR. With over 50 offices globally, an extremely diverse project portfolio, and double-digit year-over-year revenue growth, the opportunities to make your mark are limitless! In this role, you will be a member of our highly reputable cost management and estimating team. The cost team delivers solutions to clients in the areas of conceptual estimating, budget development, cost planning, feasibility studies, value management, economic forecasting, milestone reports, pre- and post-contract auditing, change order review and reconciliation, BIM 5D cost modeling, LEED cost analysis, life cycle costing, and more. We encourage you to research us to learn more about our outstanding reputation within this service line. We are currently hiring a Senior Project Controls Manager to support our team in the Norwood, MA area. This role will be focused on supporting our life sciences client on a variety of projects, focusing on cost forecasting and analyzing data. ResponsibilitiesDevelop an accurate forecast of the cost, size, and duration of future projects.Collect and analyze data on all of the factors that can affect costs, such as materials, labor, location, duration of the project, and special machinery requirements.Develop financial budgets, analyze, review, and document the requirements of a project throughout its lifecycle.Develop a cost summary for the entire project, which includes the costs of labor, equipment, materials, subcontractors, overhead, taxes, insurance, markup, and any additional costs that may affect the project.Estimate cost and schedule risk analysis, cash flow analysis, and developing historical cost data for benchmarking purposes.Lead risk identification process and run Monte Carlo simulation to determine project contingency.Input data into various programs and maintain various cost and forecasting accuracy and assist with other project management support tasks as needed.Support project set up in SAP working closely with property accounting and finance.QualificationsBachelor's Degree in Construction Management/Engineering, Civil/Electrical/Mechanical Engineering, Quantity Surveying, or Architecture is highly preferred. A combination of education and work experience will also be considered in lieu of degree.10 years' of experience in a project management or construction management field.3 years' of experience working in the biopharmaceutical sector.Advanced skill level in Excel and intermediate knowledge of Windows, Word, PowerPoint, Publisher, and Outlook.Knowledge of On-Screen Takeoff and/or Success Estimating Software is a plus.Have more questions? Chat with a Recruiter on our careers website! It takes five minutes to apply to this job and we will provide feedback within five business days.#LI-EG1 Cumming Group provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.PI240563950

As the Quality Assurance Supervisor, you are a leader for the Quality Assurance team at MilliporeSigma Norwood, reporting to the Quality Manager. The QA Supervisor is the driving force behind the site's commitment to the ISO 9001:2015 Quality Management System (QMS) standard, as well as Life Science Divisional Quality System requirements. Provide expert guidance in resolving complex quality issues, ensuring compliance with rigorous site standards Lead and inspire a high-performing team of 2-3 professionals, driving compliance with applicable standards, regulations and company requirements, and exceeding quality expectationsNurture a dynamic quality culture within the team, fostering continuous improvement and ensuring adherence to standards and best practicesProactively monitor and analyze metrics and key performance indicators (KPIs) related to Quality at the site, identify positive and negative trends, and implement data-driven strategies for enhanced quality outcomesEnsure critical investigations are completed successfully and according to established protocols; lead or assist in conducting in-depth analyses of out-of-specification (OOS), Corrective and Preventive Action (CAPA), Complaint, Deviation, Change Controls, and Root Cause Analysis (RCA).Lead internal ISO 9001 QMS audits and actively participate in external audits, leveraging expertise to ensure compliance with regulations and customer expectations/requirementsProvide QA information and support for new product introductionsRespond to QA-related customer questionsWork with the QA team to write, review, and approve Operating Procedures, Work Instructions, and Forms for the QA group, and to provide Quality assistance/input to other departments as they develop their documentationAct as the primary point of contact and site expert for the document control systemAct as the primary point of contact and site expert for the Supplier Quality Management systemMonitor the production floor, QC labs, and DC warehouses for any quality-related issues, taking prompt action and collaborating closely with stakeholders to swiftly resolve issuesLead or assist (as applicable) process improvement initiatives and projects, leveraging your expertise to drive continuous improvement of quality-related practices, methods, and systems Who you are:Minimum Qualifications:Bachelor's Degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biotechnology, etc.) or a Bachelor's Degree in an engineering discipline (e.g. Chemical, Process, Mechanical, etc.)5+ years industry experience2+ years leadership or management experienceORMaster's Degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biotechnology, etc.) or a Master's Degree in an engineering discipline (e.g. Chemical, Process, Mechanical, etc.)2+ years industry experience2+ years leadership or management experience Preferred Qualifications:Knowledge/Experience with ISO 9001ISO 9001 Lead AuditorTrackWise, SAP and Document Control experienceSupplier quality management experienceExperience communicating across all levels of an organization, and with customersExcellent writing skills and experience writing technical documentation and reportsAbility to manage multiple projects/tasks/priorities simultaneouslyExcellent problem solving and time management skillsKnowledge of data analysis, presentation, and experimental designHigh level of proficiency in Microsoft Office suite programs and the ability to learn new software