Executive Director, Research & Development Quality Assurance (RDQA)
Moderna Therapeutics
Pharmaceutical Industry
Cambridge, MA - USA
Vice President
Experteer Overview
In this role you will lead Moderna’s global R&D quality strategy, shaping governance across GCP, GLP, GCLP and GVP. You’ll partner with Clinical, Non-Clinical, Research, and Pharmacovigilance to ensure-end regulatory compliance and patient safety. You will build a high-performing QA organization in Cambridge and drive a data-driven quality culture with a focus on continuous improvement and risk-based oversight. This leadership position offers strategic impact across the full R&D lifecycle and opportunities to modernize quality through digital tools.
Compensation / Benefits
- Best-in-class healthcare coverage
- well-being resources (fitness, mindfulness, mental health)
- family planning benefits
- generous paid time off
- savings and investment opportunities
- location-specific perks and extras
Responsibilities
- Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna’s development portfolio
- Define and execute a forward-looking quality strategy aligned with global regulations and Moderna’s innovation agenda
- Act as primary Quality business partner to R&D leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance
- Embed risk-based quality management into study design, data generation, and vendor oversight
- Serve as Quality leader during global regulatory inspections (FDA, EMA, MHRA) and drive timely resolution of findings
- Drive modernization of vendor oversight and shared accountability models to improve external partnerships
- Build and lead a high-performing R&D QA team rooted in scientific credibility and operational excellence
- Enhance Quality Culture across R&D with real-time quality management and continuous feedback loops
- Establish and track quality metrics and leading indicators for risk mitigation and compliance
- Own end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness
- Oversee Pharmacovigilance Quality System (GVP) including signal management and safety database validation
- Collaborate to maintain a fit-for-purpose R&D QMS that supports innovation and agility
- Monitor regulatory intelligence and update internal systems accordingly
Key requirements
- Bachelor’s degree in life science or related field; advanced degree preferred
- 18+ years of progressive Quality experience in biopharma with deep GCP, GLP, GCLP and GVP expertise
- 15+ years leading multifunctional quality organizations in R&D with budget and resource management
- Experience building high-performing teams and continuous improvement culture
- Proven history of global audit programs and hosting health authority inspections with positive outcomes
- Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines incl. ICH E2 and EU PV
- Strong collaboration and influence across Clinical, Non-Clinical, PV, Regulatory, and Digital groups
- Excellent strategic thinking, risk-based decision-making, analytical and communication skills
- Agile and growth mindset; thrives in rapid growth and innovation environments
Description
In this role you will lead Moderna’s global R&D quality strategy, shaping governance across GCP, GLP, GCLP and GVP. You’ll partner with …
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