Associate Director, QA Clinical Operations DP at Sarepta Therapeutics

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 WellnessSupport for CaregiversFor a full list of our comprehensive benefits, see our website: The Importance of the Role The Associate Director of QA Clinical Operations DP will manage a team responsible for providing quality oversight of cGMP activities at Contract Manufacturing Organizations (CMOs) and service providers used to manufacture, Drug Products (DP) for clinical products. This individual is part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to ensure product quality and compliance. Activities include oversight of process performance qualifications, technology transfers, pre-approval inspection readiness at contract sites, investigations, change controls, and batch disposition. He/she will be responsible for the coordination of the activities of multiple areas in departments with responsibility for results. Objectives with significant impact on the department and organization.The Opportunity to Make a Difference Generally provides direction to team members around prioritization of deliverables related to lot releaseResponsible for resource allocation and personnel developmentResponsible for triage & distribution of internal and external information to team membersCross-functionally partners with leaders for direction of programResponsible for analysis and distribution of metrics dataSolution focused; Accountable for problem-solving within teamMonitors metrics of staff and tracking against performance expectationsSupports investigation, deviation activities and CAPAs and provides general quality assurance support for the overall Quality System at Sarepta.Responsible for multiple direct reportsTypically assists executives and/or senior directors in defining organizational goals and strategic plansEstablishes final decisions on administrative or operational matters and ensures effective achievement of objectivesManages activities of two or more sections or departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors Typically works on complex issues where analysis of situations or data requires an in-depth knowledge of the companyWorks on objectives that have critical impact on functional area and the organizationTravel to Contract Manufacturing Organizations for periodic meetings is requiredMore about You BA/BS degree in a related field, 10 + years related experienceDemonstrated understanding FDA/ICH GMP/GCP/GLP/GDP requirements and practices, ability to apply and educate team members and cross-functional partnersElectronic Quality Management Systems (eQMS) knowledgeMust have extensive technical knowledge of pharmaceutical manufacturing and laboratory operationsWorking knowledge of US & ex-US regulationsAbility to apply phase-appropriate guidance to developmentProficient in Microsoft suiteWhat 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-ES1This 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 $156,000 - $195,000 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.SummaryLocation: Andover, MAType: Full time