Sr. Manager, Drug Product Quality Assurance Operations

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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: 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 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

Were always looking for solution-oriented critical thinkers.

So if youre 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 Sareptas 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 $136000 - $170000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.