Senior Manager, Clinical QA

Sarepta Therapeutics
United States, Ohio, Columbus
Feb 19, 2025
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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 reports to the Associate Director, Director, or Senior Director of Research and Clinical Development QA Nonclinical, or directly to the head of Research & Clinical Development QA in the absence of an immediate supervisor in R&CD QA Nonclinical Quality. The Senior Manager will be responsible for providing general QA Compliance and Quality System oversight to Sarepta, Columbus, OH site in support of nonclinical and clinical sample testing studies and validation of bioanalytical and biomarker assays. This position will liaise with Gene Therapy Center of Excellence (GTCOE) and Translational Biology personnel, as well as external groups including contract and consulting auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GLP/GCLP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance. The Opportunity to Make a Difference Primary responsibility for compliance monitoring of GLP/GCLP Quality Management System for assigned Sarepta site(s) and developing and implementing Quality System monitoring improvements as needed. Planning, conducting, and recording QAU compliance monitoring activities, including but not limited to, protocol and protocol amendment reviews, in-study inspections, and data and/or report (and report amendment) audits without supervision, with latitude to make decisions to achieve objectives defined by line management, following established QAU procedures and general instruction on process and desired outcome. Coordinating cross-functional deliverables, and participating and contributing as a team member, taking responsibility for a portion of the team's milestones/deliverables. Receiving assignments in the form of objectives and determining how to use resources to meet schedules and goals, with latitude to make decisions to achieve the objectives defined by line management. Predominantly working with established procedures while proposing new ideas and methodologies and changes to policies and established procedures that affect the immediate organization. Managing the work efforts of the assigned team. Exercising judgement utilizing standard methods and techniques. Working on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends. Facilitating and supporting GLP/GCLP regulatory inspection and inspection readiness activities. Working on objectives that have significant impact on unit and the organization. Overseeing, scheduling, conducting and documenting facility and process inspections for conformance with applicable regulations (e.g., GLP), standards, and applicable standard operating procedures. Generating and reporting on Quality Metrics, based on study and facility/process monitoring outcomes. More about You BS/BA Degree in a scientific discipline 8+ years of experience in a related industry 4+ years in a Quality Assurance role. Must have solid understanding of nonclinical or clinical biological and bioassay validations and sample analyses according to FDA and ICH Guidance documents, as well as clinical laboratory and facility operations, including vivarium. Excellent organizational skills. Ability to work independently and in team environments. Demonstrated understanding of FDA and Global GLP/GCP/GCLP requirements and practices, ability to apply and educate team members. Familiarity with GLP Good Documentation Practices Experience working with document control systems and electronic QMS preferred. Demonstrated experience with Corrective and Preventive Action programs and reviewing Investigation /Deviations. 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-Onsite #LI-ES1 This position requires work on site at one of Sarepta's facilities in the United States. The targeted salary range for this position is $125,600 - $157,000 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.