Testing 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 perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. Reporting to the Validation Manager, CQV, the Engineer II will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance. Here's What You'll DoPerform commissioning, qualification, and validation activities for Moderna's GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met.Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards.Support new equipment qualification activities for capital and operational projects.Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.).Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program.Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.Drive results by owning and completing validation initiatives / projects against identified timelines.Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.Additional duties as may be assigned from time to timeHere's What You'll Need (Basic Qualifications)B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.). Master's degree in above discipline preferred.Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environmentsStrong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).Here's What You'll Bring to the Table (Preferred Qualifications)Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.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. Must be able to be able to find true root cause and path forward for complex problems. 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 leadership decisions. Technical writing skills required.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 manager. Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.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) -

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 .

FM Approvals is an international leader in third-party testing and certification services. We test property loss prevention products and services-for use in commercial and industrial facilities-to verify they meet rigorous loss prevention standards of quality, technical integrity and performance. How? By employing a worldwide certification process that's backed by scientific research and testing, and over a century of experience.The FM APPROVED mark is recognized and respected worldwide. Our certification instills confidence and commands respect in your marketplace.Prepares and maintains current Surveillance Audit files, electronic and hard copy, consisting of customer site details, audit report findings and recommendations, billing data, and travel information.Interacts with engineers, auditors, and customers to facilitate the surveillance audit process.Provide support on special project activities in support of the Quality Assurance function.High School diploma or equivalent.2-5+ years of administrative experience supporting a work group or manager.Excellent interpersonal and written communication skillsStrong organizational skills and attention to detailsAbility to establish and/or maintain filing systemsStrong analytical skillsAbility to handle confidential information and materialMicrosoft Office SuiteThe final salary offer will vary based on geographic location, individual education, skills, and experience. The position is eligible to participate in FM Approvals comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.FM Approvals is an Equal Opportunity Employer and is committed to attracting, developing, and retaining a diverse workforce.#LI-TA1