Director, Corporate Quality - GCP

Role: Director, Corporate Quality overseeing GCP and GLP compliance across Sarepta's clinical development and real-world evidence programs, ensuring FDA, ICH, and international standards adherence. Responsibilities: provide strategic quality leadership, partner with clinical, non-clinical, research, and pharmacovigilance teams; manage vendor and investigator site compliance; lead CAPA development; review clinical documentation; develop audit plans; support inspection readiness; contribute to QMS improvements. Requirements: BS/BA in a scientific discipline; 12+ years' industry experience with 8+ years in Clinical Quality Assurance, including audits; deep knowledge of GCP, GLP, FDA regulations, ICH guidelines, and global trial conduct; experience supporting regulatory inspections and QMS development; strong interpersonal skills. Preferred: advanced degrees, non-clinical QA experience. HighValue: global clinical trial oversight, regulatory compliance, GxP systems, internal/external audits, inspection readiness. Collaboration: partners closely with cross-functional R&D teams. WorkSetup: hybrid (U.S. based), up to 10% travel.