Senior Director, Corporate Quality – PV
Sarepta Therapeutics
June 30, 2026
Remote friendly (Bedford, MA)
United States
Corporate Functions
The Sr. Director, Corporate Quality, Pharmacovigilance will manage GVP quality oversight and the GVP-related audit program, and provide regulatory/GVP guidance.
Primary Responsibilities:
- Develop and maintain the internal/external Corporate Quality annual audit plan for GVP, REMS, PV vendors, interfaces, processes, and partners; update based on risks/priorities.
- Provide oversight and support to the global Pharmacovigilance (PV) function to identify risks and mitigation strategies.
- Design long-term GVP-related audit strategy to meet regulatory requirements.
- Oversee timely audit report development, distribution, follow-ups, and CAPA completion.
- Collaborate with stakeholders to ensure audit plan execution.
- Identify systemic gaps, coordinate remediation, and escalate critical noncompliance/slow urgency as appropriate.
- Lead compliance investigations, identify root cause, and provide metrics/trending to functional and senior management.
- Develop/review SOPs, policies, and related documents.
- Advise on pharmacovigilance compliance matters and support metrics/trending and CAPA implementation.
- Support inspection readiness and regulatory inspections.
Qualifications:
- Bachelor’s in Life Sciences; 15 years in pharmaceutical/biotech drug development (Advanced degree preferred).
- Minimum 10 years in GCP/GVP QA; at least 5 years focused GVP QA.
- Experience with clinical trial teams.
- Strong global clinical trial knowledge; ICH E6 (R2), FDA, and EU requirements.
- Experience facilitating/supporting regulatory authority inspections.
- Direct experience developing/overseeing Quality Management Systems.
Skills:
- Interpersonal integrity and cross-functional relationship building.
- Technical writing (briefings, positions, investigations, audit reports, SOPs).
- Knowledge of drug development/clinical operations/regulatory affairs/GVP auditing; regulatory knowledge by region.
- Collaboration, strong judgment, decision-making, and project management.
Benefits (as stated): Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions:
- Candidates must be authorized to work in the U.S.
- Hybrid role: on-site at U.S. facilities and occasional company-sponsored in-person events.
Primary Responsibilities:
- Develop and maintain the internal/external Corporate Quality annual audit plan for GVP, REMS, PV vendors, interfaces, processes, and partners; update based on risks/priorities.
- Provide oversight and support to the global Pharmacovigilance (PV) function to identify risks and mitigation strategies.
- Design long-term GVP-related audit strategy to meet regulatory requirements.
- Oversee timely audit report development, distribution, follow-ups, and CAPA completion.
- Collaborate with stakeholders to ensure audit plan execution.
- Identify systemic gaps, coordinate remediation, and escalate critical noncompliance/slow urgency as appropriate.
- Lead compliance investigations, identify root cause, and provide metrics/trending to functional and senior management.
- Develop/review SOPs, policies, and related documents.
- Advise on pharmacovigilance compliance matters and support metrics/trending and CAPA implementation.
- Support inspection readiness and regulatory inspections.
Qualifications:
- Bachelor’s in Life Sciences; 15 years in pharmaceutical/biotech drug development (Advanced degree preferred).
- Minimum 10 years in GCP/GVP QA; at least 5 years focused GVP QA.
- Experience with clinical trial teams.
- Strong global clinical trial knowledge; ICH E6 (R2), FDA, and EU requirements.
- Experience facilitating/supporting regulatory authority inspections.
- Direct experience developing/overseeing Quality Management Systems.
Skills:
- Interpersonal integrity and cross-functional relationship building.
- Technical writing (briefings, positions, investigations, audit reports, SOPs).
- Knowledge of drug development/clinical operations/regulatory affairs/GVP auditing; regulatory knowledge by region.
- Collaboration, strong judgment, decision-making, and project management.
Benefits (as stated): Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions:
- Candidates must be authorized to work in the U.S.
- Hybrid role: on-site at U.S. facilities and occasional company-sponsored in-person events.