Job Description

The Role:

In this highly visible leadership role, you will set the strategy and provide end-to-end quality oversight for Moderna’s entire portfolio of clinical and commercial products. You will lead a global team of Product Quality Leads (PQLs) and specialists who review and approve all CMC-related health-authority submissions (INDs, BLAs, MAAs, variations and supplements), ensure data integrity of technical reports, and maintain alignment with Moderna’s Quality Management System (QMS). In addition, you will lead a team of technical quality professionals supporting product quality lifecycle governance —from raw-material and product specifications. through commercial Annual Product Quality Reviews—working side-by-side with Sr. Leaders in CMC, MS&T, AS&T, QC, TD, and Regulatory partners to drive right-first-time submissions, robust process performance and sustained license compliance.

Here’s What You’ll Do:

• Set global product quality strategy across early, late and post‑approval phases, integrating regulatory, technical development and commercial needs into a single lifecycle plan.

• Lead and develop the Product Quality Lead (PQL) organization—establish objectives, coach technical depth, and ensure seamless execution of dossier content, quality justifications and health‑authority responses.

• Serve as Quality signatory for all major CMC submissions (IND/CTA, BLA, MAA, global variations), ensuring data accuracy, scientific soundness and alignment with internal standards and external regulations.

• Own specification governance for raw materials, intermediates, drug substance and drug product; chair the Specification Review Board and partner with Raw Materials QA to maintain global consistency.

• Co‑chair the CMC Value‑Chain Council with Regulatory‑CMC, driving proactive risk management, change implementation, and mitigation of critical investigations/deviations affecting product quality.

• Oversee preparation and executive presentation of Annual Product Quality Reviews (APQRs) for all commercial products, ensuring trending, CAPA effectiveness and license commitments are met.

• Guide technical development quality oversight—provide quality input to process development, technology transfer, comparability and stability strategies; approve key technical protocols and reports.

• Represent Quality on global governance forums (Portfolio Steering, Launch Readiness, Change Control Board, CMC Review Committee) and during health‑authority inspections as the primary product‑quality contact.

• Drive digital excellence by championing electronic specification management, knowledge‑management repositories and advanced analytics for product and process monitoring.

• Foster a culture of continuous improvement—set meaningful KPIs, benchmark industry best practices and sponsor cross‑functional Kaizen/OE projects aligned with Moderna’s Bold, Relentless, Curious and Collaborative values.

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Basic Qualifications):

• Bachelor’s degree in Chemistry, Biology, Engineering or related science discipline.

• 15+ years of progressive Quality or Regulatory CMC experience in biopharma, including >5 years leading global or multi‑site teams.

• Demonstrated authorship/approval responsibility for major CMC submissions and direct participation in FDA / EMA inspections.

• Deep knowledge of ICH Q8–Q12, FDA / EMA / PMDA biologics regulations, and phase‑appropriate GMPs.

Here’s What You’ll Bring to the Table (Preferred Qualifications):

• Advanced degree (MS, PhD, PharmD, MBA) strongly preferred.

• Proven success leading Product Quality or Lifecycle Management functions across clinical and commercial portfolios.

• Expertise in mRNA, lipid nanoparticle or other advanced biologic modalities.

• Experience governing global raw‑material qualification and specification programs.

• Working knowledge of Quality Risk Management, statistical trend analysis and digital quality tools (e‑QMS, data‑visualization platforms).

• Change‑agent mindset with the ability to influence SVP/EVP‑level stakeholders in a matrixed, fast‑growth environment.

• Excellent written and oral communication skills; able to translate complex technical issues for executive and regulatory audiences.

• A desire to make an impact as part of a transformational company that is Bold, Relentless, Curious and Collaborative.

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since 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.

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.

Our Working Model

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 leavesandaccommodations@modernatx.com.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company’s ability to obtain any required export control license.

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