Senior Director, Pharmacovigilance Quality Assurance

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 and follow us on X LinkedInand Facebook.

Role Summary:

The Senior Director Pharmacovigilance Quality Assurance (PVQA) leads the strategy governance and execution of Dynes 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 Dynes 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.

PrimaryResponsibilitiesInclude

Enterprise Strategy & Leadership

• Define and own the global PVQA strategy aligned to Dynes development and commercialization roadmap.
• Serve as Dynes 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.
• Represent PVQA in regulatory authority interactions external audits health authority inspections and executive-level quality discussions.
• Partner cross-functionally to embed a culture of quality accountability and continuous improvement across PV and related functions.

Quality Systems Governance & Risk Management

• Own the end-to-end PV Quality Management System ensuring scalability compliance and operational efficiency across preclinical clinical and future commercial stages.
• Establish and monitor enterprise PV quality metrics and KPIs translating trends into actionable improvements and executive-level reporting.
• Oversee deviations quality issues CAPAs effectiveness checks and quality events ensuring timely resolution robust root cause analysis and systemic improvement.
• Establish a risk-based PV quality framework to proactively identify assess escalate and mitigate risks across programs vendors systems and regulatory submissions.

Audit Inspection & External Oversight

• Lead global PV audit and inspection strategy including internal audits vendor audits health authority inspections and continuous inspection readiness.
• Serve as the senior inspection lead ensuring consistent messaging rapid issue resolution compliant responses and effective CAPA execution.
• Oversee Pharmacovigilance System Master File governance and ensure alignment with applicable regulatory expectations.
• Provide quality oversight for PV vendors and partners through defined governance KPIs audits performance reviews and issue escalation pathways.

Cross-Functional Impact & Commercial Readiness

• Partner with Clinical Development Regulatory Quality IT Translational and Commercial readiness teams to ensure end-to-end PV compliance and inspection readiness.
• Influence system strategy for safety databases validation data integrity and compliance including applicable computerized system requirements such as 21 CFR Part 11.
• Enable efficient high-quality regulatory submissions by supporting IND through BLA/NDA activities and future commercial launch readiness.
• Develop and scale GVP training communication and capability-building programs that strengthen PV quality awareness across the organization.

Success Measures

• Sustained inspection readiness and successful regulatory inspection outcomes.
• A mature scalable PV Quality Management System that supports pipeline expansion and commercial readiness.
• Measurable improvement in audit findings CAPA closure compliance KPIs and vendor performance.
• Clear executive-level visibility into PV quality risks decisions and mitigation plans.
• Development of an engaged capable PVQA team and sustainable talent pipeline.

EducationandSkillsRequirements

• Bachelors degree in a scientific discipline. Masters degree preferred.
• 15 years of progressive experience in the pharmaceutical or biotechnology industry including significant leadership experience in PV Quality
• In-depth knowledge of global pharmacovigilance regulations (e.g. FDA EMA) guidelines (e.g. ICH GVP GxP) and safety reporting requirements.
• Broad drug experience across all clinical phases (Phase I to BLA/NDA).
• Strong understanding of GVP Quality for pre-clinical clinical and commercial stages.
• Hands-on experience with pharmacovigilance systems and safety databases including validation audits and compliance assessments.
• Proven experience in developing and implementing risk-based clinical quality assurance programs.
• Experience leading PVQA audits and inspections and responding to regulatory findings.
• Experience overseeing PV vendor governance audit programs performance metrics and quality issue escalation.
• Strong executive communication skills with the ability to present complex quality events risks and recommendations clearly and concisely.
• Ability to concisely present quality events to internal stakeholders.
• Excellent interpersonal verbal and written communication skills.
• Working knowledge of therapeutic areas is beneficial.
• Results-oriented with the ability to set objectives manage competing priorities and adapt to dynamic timelines.
• Flexible and creative problem-solving skills.
• Highly collaborative team player fostering open communication and cooperation.

#LI-Onsite

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education experience job-related knowledge and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job the level of knowledge and skill typically required and the scope of responsibility but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned including work in other functional areas to cover absences or relief to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age color disability gender national origin race religion sexual orientation veteran status or any classification protected by federal state or local law.