Senior Director, Pharmacovigilance Quality Assurance

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. 
• 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. 

Education and Skills Requirements 

• Bachelor’s degree in a scientific discipline. Master’s 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. 

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