Director, Pharmacovigilance Quality Assurance
Dyne Therapeutics
11 days ago
Remote friendly (Waltham, MA)
United States
Operations
Role Summary
The Director of Pharmacovigilance Quality Assurance (PVQA) leads the quality and compliance of pharmacovigilance activities, ensuring adherence to global regulatory standards and company policies. Oversees development and implementation of quality programs, audits, and inspection readiness, and leads Dyne’s Pharmacovigilance Quality Management System (QMS).
Primary Responsibilities
- Lead design, implementation, and continuous improvement of the Pharmacovigilance QMS (policies, procedures, standards)
- Develop and execute risk-based quality plans across clinical and commercial programs
- Plan, conduct, and support GVP audits, inspections, and inspection readiness (including PSMF contributions)
- Oversee quality systems and processes (deviations, CAPAs, KPIs, quality indicators, audit tracking/reporting)
- Identify, assess, and escalate quality/compliance risks; drive mitigation for regulatory submissions and patient safety
- Ensure compliance with global GVP regulations, ICH guidelines, and company standards
- Provide expert guidance on GVP compliance trends
- Lead vendor qualification, oversight, and audit readiness for PV service providers
- Develop and deliver PV training, SOPs, and policies
- Partner cross-functionally (Clinical Development, Translational Biomarkers, IT) for compliance and safety database validation (e.g., 21 CFR Part 11)
- Support global regulatory submissions and IND-related activities
- Advise stakeholders on GVP compliance issues/trends; co-host regulatory audits
Education And Skills Requirements
- Bachelor’s degree in a scientific discipline; advanced degree preferred
- 10+ years in pharmacovigilance; at least 5 years in PV quality assurance (or equivalent PV+QA)
- In-depth knowledge of global pharmacovigilance regulations (FDA/EMA) and guidelines (ICH/GVP/GxP)
- Broad drug experience across clinical phases (Phase I to BLA/NDA)
- Hands-on experience with PV systems and safety databases (validation, audits, compliance assessments)
- Proven risk-based clinical quality assurance program experience
- Experience leading PVQA audits/inspections and responding to findings
- Strong communication and presentation skills; results-oriented; collaborative; creative problem-solving
Compensation
MA pay range: $190,000 - $232,800 USD.
The Director of Pharmacovigilance Quality Assurance (PVQA) leads the quality and compliance of pharmacovigilance activities, ensuring adherence to global regulatory standards and company policies. Oversees development and implementation of quality programs, audits, and inspection readiness, and leads Dyne’s Pharmacovigilance Quality Management System (QMS).
Primary Responsibilities
- Lead design, implementation, and continuous improvement of the Pharmacovigilance QMS (policies, procedures, standards)
- Develop and execute risk-based quality plans across clinical and commercial programs
- Plan, conduct, and support GVP audits, inspections, and inspection readiness (including PSMF contributions)
- Oversee quality systems and processes (deviations, CAPAs, KPIs, quality indicators, audit tracking/reporting)
- Identify, assess, and escalate quality/compliance risks; drive mitigation for regulatory submissions and patient safety
- Ensure compliance with global GVP regulations, ICH guidelines, and company standards
- Provide expert guidance on GVP compliance trends
- Lead vendor qualification, oversight, and audit readiness for PV service providers
- Develop and deliver PV training, SOPs, and policies
- Partner cross-functionally (Clinical Development, Translational Biomarkers, IT) for compliance and safety database validation (e.g., 21 CFR Part 11)
- Support global regulatory submissions and IND-related activities
- Advise stakeholders on GVP compliance issues/trends; co-host regulatory audits
Education And Skills Requirements
- Bachelor’s degree in a scientific discipline; advanced degree preferred
- 10+ years in pharmacovigilance; at least 5 years in PV quality assurance (or equivalent PV+QA)
- In-depth knowledge of global pharmacovigilance regulations (FDA/EMA) and guidelines (ICH/GVP/GxP)
- Broad drug experience across clinical phases (Phase I to BLA/NDA)
- Hands-on experience with PV systems and safety databases (validation, audits, compliance assessments)
- Proven risk-based clinical quality assurance program experience
- Experience leading PVQA audits/inspections and responding to findings
- Strong communication and presentation skills; results-oriented; collaborative; creative problem-solving
Compensation
MA pay range: $190,000 - $232,800 USD.