Sr. Manager, Drug Product Quality Assurance Operations at Sarepta Therapeutics

Bedford, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

170000.0

Posted On

18 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality assurance, Drug product manufacturing, Batch record review, Lot disposition, Sterile injectable manufacturing, CMO oversight, CTL oversight, Deviation management, CAPA, Laboratory investigations, Quality technical agreements, Pharmaceutical manufacturing, Regulatory compliance, Cross-functional leadership, Microsoft suite

Industry

Biotechnology Research

Description

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 For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role The Senior Manager, Quality Assurance Operations will lead the quality operations for clinical and commercial sterile drug product related to CMOs. This includes oversight of contract manufacturing and contract labs to ensure a robust and compliant quality program. The position will oversee the drug product batch record review and disposition process. The position will encompass various tasks including, but not limited to the following: • 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. The Opportunity to Make a Difference 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. More about You BA/BS degree in a related field 8 + years related experience Proficient in Microsoft suite Must have technical knowledge of Pharmaceutical manufacturing and laboratory operations. What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid #LI-ES1 This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $136,000 - $170,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Responsibilities

The Senior Manager will lead quality operations for sterile drug products, overseeing batch record reviews, lot disposition, and contract manufacturing vendor compliance. They will also manage investigations, including deviations and CAPA activities, while collaborating cross-functionally to support product release.