Executive Director, Global Product Quality and Lifecycle Management

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