Executive Director, R&D Quality Assurance — Global Leader

Regulatory Toolkit; Cambridge (MA); Vor Ort; USD 225.000 - 405.000; Vollzeit

Zusammenfassung

Moderna seeks a senior Quality executive to shape and lead the RDQA program from Cambridge. You will set strategic direction, governance, and an operational excellence framework for Quality within R&D, spanning GCP, GLP, GCLP and GVP, embedding quality into the lifecycle from research to late-stage development.

You will partner with Clinical Development, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research to ensure regulatory compliance, scientific integrity, and patient

Qualifikationen

• 15+ years of progressive biopharmaceutical experience with deep GCP/GLP/GCLP/GVP expertise.
• 10+ years leading multifunctional quality organizations in R&D.
• Experience hosting health authority inspections with FDA/EMA/MHRA/PMDA.
• Extensive knowledge of ICH/GxP regulations and EU PV guidance.

Aufgaben

• Provide governance of GCP, GVP, GLP, and GCLP across Moderna’s development portfolio.
• Define and execute a robust global quality strategy aligned with regulatory requirements.
• Act as Quality partner to R&D leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance.
• Embed risk-based quality management in study design, data generation, and vendor oversight.
• Serve as Quality leader during global regulatory inspections and ensure timely findings resolution.
• Drive modernization of vendor oversight and external partnership performance.

Kenntnisse

Leadership and people development

Cross-functional collaboration

Strategic thinking

Risk-based decision making

Communication

Ausbildung

Bachelor’s degree in life science or related field

Advanced degree preferred

Jobbeschreibung

Moderna seeks a senior Quality executive to shape and lead the RDQA program from Cambridge. You will set strategic direction, governance, and an operational excellence framework for Quality within R&D, spanning GCP, GLP, GCLP and GVP, embedding quality into the lifecycle from research to late-stage development.

You will partner with Clinical Development, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research to ensure regulatory compliance, scientific integrity, and patient