Sarepta
Associate Director, Drug Product Quality Assurance Operations
Bedford, MA · Director
No sponsorship$161k-$201kDetected 1 day ago
CRISPRLeadership
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.
- This includes oversight of contract manufacturing and contract labs to ensure a robust and compliant quality program.
Responsibilities
- Involved in developing, modifying and executing company policies that affect immediate operations, and may also have company-wide effect.
- Manage team of QA personnel responsible for sterile injectable drug product batch record review and lot disposition.
- Coordinate cross-functional deliverables to support product release.
- Oversight of commercial and clinical drug product manufacturing contract vendors (CMO and CTL), includes ensuring obligations are met per quality technical agreements and support of CMO and CTL quality systems.
- Lead Investigation activities (Deviations, Laboratory Investigations, CAPA activities, etc.) associated with general quality oversight, OOS, product complaints, field alerts and/or recalls
- Collaborate within QA and cross functionally on projects as applicable.
- Support for Caregivers
Requirements
- BA/BS degree in a related field
- Must have technical knowledge of Pharmaceutical manufacturing and laboratory operations.
Compensation
- The targeted salary range for this position is $160,800 - $201,000 per year.
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.