The RoleIn this role, you will provide oversight, strategic direction, management support and guidance for building and maintaining Moderna's R&D Quality Management System (QMS), focusing on GCP/GLP, GCLP/GVP/CSV activities conducted by Moderna and its service providers. You will be responsible for establishing strategies to drive optimal performance of the R&D QMS through management of key projects and programs impacting the QMS, ensuring consistent implementation of deliverables across the R&D organization and proactive identification and mitigation of potential risks impacting the QMS . Additionally, you will support the appropriate integration a oversight of the R&D QMS within the Moderna Global QMS. The appointee will also be responsible to champion a quality culture within the R&D organization and drive toward a sustained state of inspection readiness.Here's What You'll DoPartner closely with R&D colleagues to develop and maintain program/project plans and deliverables, ensuring appropriate communication of status to key stakeholders and R&D Leadership.Collaborate with R&D colleagues to assess/support the state of the R&D QMS by evaluating the major elements for both current state and as part of the ongoing assessment of the QMS for continuous improvement.Support oversight of all R&D quality documents to ensure compliance to applicable regulations and internal requirements.Lead and contribute to strategic and operational improvement initiatives impacting the QMS.Provide active R&D representation/participation in the Global QMS organization to ensure appropriate R&D GxP integration.Actively participate as a Subject Matter Expert for health authority inspections of Moderna as it relates to the R&D QMS (e.g., procedural documents, training, issue management, risk management).Contribute to the continuing development of a quality culture at Moderna.Additional duties as may be assigned from time to time.Here's What You'll Need (Minimum Qualifications)BS/BA, MS or PhD and a minimum of 12-15, 8-10, 10 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.Here's What You'll Bring to the Table (Preferred Qualifications)Knowledge of metrics and data analytics best practices as they relate to a QMS.Strong knowledge of project/program management tools and methodology.Expert level knowledge of Excel, PowerPoint and other office applications.Strong knowledge of relevant FDA, EU, ICH GCP guidelines.Knowledge of relevant FDA, EU, ICH guidance for GVP, CSV and GLP.Experience working with CROs, vendors, and relationship management.Strong interpersonal skills and ability to interact effectively with all levels within the organization.Ability to solve complex problems taking a broad perspective to identify innovative solutions.Ability to manage multiple projects in a fast-paced environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.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-
