Executive Director, Development Quality

Role: Executive Director of Development Quality, responsible for strategic and operational quality leadership across all therapeutic areas from first-in-human trials through lifecycle management. The role acts as the quality partner to Global Drug Development and Development Operations, ensuring GxP compliance, inspection readiness, and fostering a quality culture that enables innovative, patient-centered drug development. Core responsibilities include defining quality oversight strategies, managing risk assessments, supporting regulatory interactions, and leading continuous improvement initiatives. The ED oversees quality systems, audit and inspection readiness, and leads a high-performing team, integrating quality across clinical, CMC, and medical affairs functions. Requirements: Bachelor's or higher in Life Sciences, Pharmacy, Chemistry, with 15-20+ years in pharma/biotech, including at least 10 years in Quality roles within development, regulatory, or medical affairs. Deep knowledge of GxP regulations, proven experience in inspection management, and stakeholder influence skills. Preferred: experience in global biopharma, GxP systems (e.g., Veeva Vault QMS), and exposure to novel modalities like gene or cell therapies. The position reports to the VP of R&D Quality, with a focus on strategic leadership and cross-functional collaboration within a matrix environment.