Senior Director, Corporate Quality - PV

About the role

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 Sr. Director, Corporate Quality, Pharmacovigilance will be responsible for the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance. The Opportunity to Make a Difference This position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract 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 GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance. Primary responsibilities include: Participate in the development of the internal and external Corporate Quality annual audit plan for GVP, REMS, PV vendors, interfaces, processes and preferred business partners and update the audit plan as needed based on identified risks and priorities Provide oversight and support to global Pharmacovigilance (PV) function to identify risks and risk mitigation strategies Design the long-term audit strategy for GVP-related audits to meet applicable regulatory requirements. Oversee the timely development and distribution of audit reports and follow up actions Collaborate with key stakeholders to ensure audit plan execution. Ensure the corrective and preventive actions are appropriately identified and completed in a timely manner. Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical noncompliance and/or lack of urgency in remediation to senior management. Work collaboratively to perform investigations to identify root cause of compliance issues and provide appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management. Develop and/or review SOPs, Policies, documents etc., as needed Serve in an advisory/consultative role in compliance related matters for pharmacovigilance and support the internal team in evaluating metrics and trending exercises and/or identifying implementing corrective and preventive actions. Participate in inspection readiness and preparedness activities and support regulatory inspections More about You Education and Skills Requirements: Bachelor's degree in Life Sciences with 15 years in pharmaceutical or biotech drug development. Advanced degree preferred. Minimum 10 years of experience in GCP/GVP QA, with at least 5 years of focused GVP QA experience Demonstrated experience working with clinical trial teams Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements. Previous experience facilitating and/or supporting Regulatory Authority Inspections Direct experience in development and oversight of Quality Management Systems Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross functional personnel at all levels Strong technical writing skills. Ability to write briefing documents, quality positions, investigations, audit reports and SOPs. Good understanding of the drug development processes, clinical operations, regulatory affairs and GVP auditing Knowledge of regulatory guidelines in different geographic regions Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems Strong judgment and decision-making skills General project management skills Candidates must be authorized to work in th

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