Senior Director, Pharmacovigilance Quality Assurance

Responsibilities

• Define and own the global PVQA strategy aligned to development and commercialization roadmaps
• Serve as subject matter expert on PV quality, regulatory expectations, and compliance risks
• Build, lead, and develop a high-performing PVQA organization
• Represent PVQA in regulatory authority interactions, external audits, and health authority inspections
• Own the end-to-end PV Quality Management System (QMS) for preclinical, clinical, and commercial stages
• Establish and monitor enterprise PV quality metrics and KPIs
• Oversee deviations, quality issues, CAPAs, and effectiveness checks
• Establish a risk-based PV quality framework to mitigate risks across programs and vendors
• Lead global PV audit and inspection strategy, including internal and vendor audits
• Provide quality oversight for PV vendors and partners through governance and performance reviews
• Partner with Clinical Development, Regulatory, Quality, IT, and Commercial teams
• Influence system strategy for safety databases, validation, and data integrity (21 CFR Part 11)

Requirements

• Bachelor’s degree in a scientific discipline (Master’s preferred)
• 15+ years of progressive experience in pharmaceutical or biotechnology industry
• Significant leadership experience in PV Quality
• In-depth knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, GVP, GxP)
• Broad drug experience across all clinical phases (Phase I to BLA/NDA)
• Hands-on experience with pharmacovigilance systems and safety databases
• Proven experience developing risk-based clinical quality assurance programs
• Experience leading PVQA audits and responding to regulatory findings
• Experience overseeing PV vendor governance and performance metrics
• Strong executive communication and interpersonal skills

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.