The RoleIn this role, you will apply established knowledge and experience in computer systems vendor audits, systems validation, and lifecycle. The Manager should be familiar with global Health Authority Regulations including US FDA, ICH and GAMP guidelines and is responsible for leading/co-leading computer system vendor and internal audits, and the oversight, review, and approval of internal GCP/GLP/GVP related computer system validation activities as needed. 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 DoLead and co-lead internal and vendor computer system audits related to GCP/GLP/GVP systems including but not limited to pre/post audit meeting, 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 Digital Technology department, system owners and business owners to implement new systems, system upgrades or modifications effectively and efficiently.Participate in the change control program for modifications to qualified systems.Deliver strategy solutions to computer systems validation based on Moderna's processes, industry guidance and regulations.Review and approve computerized system and validation 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.Travel expectations up to 30%.Additional duties as may be assigned from time to time.Here's What You'll Need (Minimum Qualifications)BS/BA with 10 to 12 years of experience or MS with 8 to 10 years of experience in 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) principals 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 required.Validation of Artificial Intelligence (AI) computerized systems and processes is desired.Experience and proficiency with CSV audit for Research (GCP, GLP, GVP) 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.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.Here's What You'll Bring to the Table (Preferred Qualifications)BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience in 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) principals 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.A desire to make an impact as part of a high-growth, transformational company that isBold, 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 classesExclusive 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 parents401k 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 peopleare 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.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 make a request to the Talent Acquisition Partner or contact the Accommodations team at ****** . (EEO/AAP Employer) #LI-LG1-
