Sarepta
Senior Director, Corporate Quality – PV
Bedford, MA · Director
No sponsorship$222k-$278kDetected 7 days ago
GCPProject ManagementAuditingFDA RegulatoryCRISPRPharmacovigilanceResearchLeadershipWritingRegulatory Affairs
About the role
- The promise of genetic medicine has arrived, and Sarepta is at the forefront.
- In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
- Director, Corporate Quality, Pharmacovigilance will be responsible for the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance.
Responsibilities
- Provide oversight and support to global Pharmacovigilance (PV) function to identify risks and risk mitigation strategies
- Design the long-term audit strategy for GVP-related audits to meet applicable regulatory requirements.
- Collaborate with key stakeholders to ensure audit plan execution.
- Develop and/or review SOPs, Policies, documents etc., as needed
- Participate in inspection readiness and preparedness activities and support regulatory inspections
- Support for Caregivers
Requirements
- Minimum 10 years of experience in GCP/GVP QA, with at least 5 years of focused GVP QA experience
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.
- Direct experience in development and oversight of Quality Management Systems
- Knowledge of regulatory guidelines in different geographic regions
- Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems
- Candidates must be authorized to work in the U.S.
Nice to have
- Bachelor's degree in Life Sciences with 15 years in pharmaceutical or biotech drug development.
- Advanced degree preferred.
Compensation
- Participate in the development of the internal and external Corporate Quality annual audit plan for GVP, REMS, PV vendors, interfaces, processes and preferred business partners and update the audit plan as needed based on identified risks
Benefits
- Financial Wellness
Visa & Work Authorization
- Candidates must be authorized to work in the U.S.
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This listing is sourced directly from Sarepta's careers page and normalized into a canonical job model.