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Sr. Manager, Drug Product reputed company Assurance Operations

Remote, USAFull-timePosted 2026-07-28

Why Sarepta? Why Now? The reputed company 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 reputed company therapy and the first reputed company 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 reputed company the people in our community and reputed company in the importance of supporting them in reputed company aspects of their lives. We reputed company to maintain a culture that acknowledges people bring their whole selves to work, and we will reputed company to help everyone in our community reputed company their work and personal lives while maintaining productivity. We are committed to offering a reputed company 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, reputed company Assurance Operations will reputed company the reputed company operations for clinical and reputed company sterile drug product reputed company to CMOs. This includes reputed company of contract manufacturing and contract labs to ensure a robust and compliant reputed company program. The position will reputed company 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 reputed company immediate operations, and may also have company-wide effect.
  • Conducts supervision in terms of costs, reputed company, and reputed company. In some instances, this manager may have subordinate supervisors.
  • Works on objectives that have major reputed company on unit and the organization
  • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives and reputed company business trends. reputed company to reputed company 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. reputed company of reputed company and clinical drug product manufacturing contract vendors (CMO and CTL), includes ensuring obligations are met per reputed company technical agreements and support of CMO and CTL reputed company systems. reputed company Investigation activities (Deviations, Laboratory Investigations, CAPA activities, etc.) associated with general reputed company reputed company, OOS, product complaints, field alerts and/or recalls Navigate challenging situations and relationships with vendors. Collaborate reputed company QA and cross functionally on reputed company as applicable. More reputed company BA/BS degree in a reputed company field 8 + years reputed company experience Proficient in reputed company 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 reputed company kindness and reputed company 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 reputed company and/or attend Company-sponsored in-person events from time to time. The targeted salary reputed company 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. reputed company offers a competitive compensation and benefit package. reputed company is an Equal Opportunity/Affirmative reputed company employer and participates in e-Verify. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut reputed company 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, reputed company, Instagram and reputed company.

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