Senior Director, Pharmacovigilance Quality Assurance

About this role

Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary:

The Senior Director, Pharmacovigilance Quality Assurance (PVQA) leads the strategy, governance, and execution of Dyne’s global pharmacovigilance quality framework. This role sets the direction for PV quality systems and ensures scalable, inspection-ready operations that support high-quality regulatory submissions and continuous patient safety assurance across the portfolio.

This leader designs and evolves Dyne’s Pharmacovigilance Quality Management System, integrating global standards with business needs across clinical and future commercial programs. They serve as a senior advisor on PV quality risks, regulatory expectations, vendor oversight, and inspection readiness while fostering a culture of quality, accountability, and continuous improvement.

This role is based in Waltham, MA.

Primary Responsibilities Include

Enterprise Strategy & Leadership

• Define and own the global PVQA strategy, aligned to Dyne’s development and commercialization roadmap.

• Serve as Dyne’s subject matter expert on PV quality, advising senior leaders on regulatory expectations, compliance risks, inspection trends, and emerging best practices.

• Build, lead, and develop a high-performing PVQA organization, including capability building, mentorship, succession planning, and talent development.

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