Dyne Therapeutics
Senior Director, Pharmacovigilance Quality Assurance
Waltham, MA · Director
Sponsorship not specifiedDetected 16 days ago
Performance ManagementPharmacovigilanceAnimal StudiesLeadershipCommunicationMentoring
About the role
- 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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- Define and own the global PVQA strategy, aligned to Dyne's development and commercialization roadmap.
- Build, lead, and develop a high-performing PVQA organization, including capability building, mentorship, succession planning, and talent development.
- Partner cross-functionally to embed a culture of quality, accountability, and continuous improvement across PV and related functions.
- Own the end-to-end PV Quality Management System, ensuring scalability, compliance, and operational efficiency across preclinical, clinical, and future commercial stages.
- Serve as the senior inspection lead, ensuring consistent messaging, rapid issue resolution, compliant responses, and effective CAPA execution.
- Provide quality oversight for PV vendors and partners through defined governance, KPIs, audits, performance reviews, and issue escalation pathways.
- Partner with Clinical Development, Regulatory, Quality, IT, Translational, and Commercial readiness teams to ensure end-to-end PV compliance and inspection readiness.
- Develop and scale GVP training, communication, and capability-building programs that strengthen PV quality awareness across the organization.
- A mature, scalable PV Quality Management System that supports pipeline expansion and commercial readiness.
Requirements
- Bachelor's degree in a scientific discipline.
- Master's degree preferred.
Benefits
- Represent PVQA in regulatory authority interactions, external audits, health authority inspections, and executive-level quality discussions.
- Lead global PV audit and inspection strategy, including internal audits, vendor audits, health authority inspections, and continuous inspection readiness.
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.