Executive Director, Research & Development Quality Assurance (RDQA)

Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna's entire development portfolio.,Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna's innovation agenda.,Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas.,Embed risk-based quality management principles into study design, data generation, and vendor oversight practices.,Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA, EMA, MHRA), ensuring timely and effective resolution of findings.,Drive modernization of vendor oversight and shared accountability models, elevating external partnership performance.,Build and lead a high-performing, solutions-oriented R&D QA team, rooted in scientific credibility and operational excellence.,Enhance Quality Culture across R&D by promoting real-time quality management, early issue detection, and continuous feedback loops.,Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance.,Own the end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness.,Oversee the Pharmacovigilance Quality System (GVP) including signal management, safety database validation, and global safety inspection preparation.,Collaborate with Global Systems & Compliance to maintain a fit-for-purpose R&D Quality Management System (QMS) that supports innovation and agility.,Monitor global regulatory intelligence and evolving external expectations, ensuring internal systems are updated accordingly.

Bachelor's degree in a life science or related field; advanced degree preferred.,15+ years of progressive experience in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials, regulatory submissions, laboratories and PV and clinical safety.,10+ years' experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals.,Expertise to oversee comprehensive resource and staffing management, building high-performing teams and fostering a culture of continuous improvement and accountability.,Experience in the development and execution of robust audit schedules, coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration.,Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes.,Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines, including ICH E2 and EU PV legislation.,Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH regulations, guidance and local legislation for clinical trials, including ICH E6 (R3).,Proven ability to collaborate and influence in a fast-paced, matrixed environment; strong cross-functional partnership skills with Clinical, Non-Clinical, PV, Regulatory, and Digital groups.,Exceptional leadership and people-development skills, with demonstrated ability to build and inspire high-performing, geographically dispersed teams.,Excellent strategic thinking, risk-based decision-making, analytical and communication skills.,Agile and growth mindset; thrives in rapid growth and embraces continuous improvement and innovation.

Bachelor's Degree

Must qualify as a U.S. person (citizen, permanent resident, asylee, or refugee) due to U.S. export control laws and access to export-controlled information.