Associate Director, Drug Product Quality Assurance Operations

Sarepta Therapeutics · United States

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness
• ​Financial Wellness
• Support for Caregivers

• Establishes operational objectives, which are reviewed by senior management, and delegates assignments to subordinates.
• Involved in developing, modifying and executing company policies that affect immediate operations, and may also have company-wide effect.
• Conducts supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors.
• Works on objectives that have major impact on unit and the organization
• Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives and current business trends.

• 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
• Navigate challenging situations and relationships with vendors.
• Collaborate within QA and cross functionally on projects as applicable.

• BA/BS degree in a related field
• 10+ years related experience
• Proficient in Microsoft suite
• Must have technical knowledge of Pharmaceutical manufacturing and laboratory operations.