Executive Director, Development Quality

Role: Executive Director, Development Quality, providing strategic and operational quality leadership across all therapeutic areas from first-in-human (FIH) through lifecycle management (LCM). Responsibilities include defining and executing quality oversight strategies, ensuring GxP compliance, inspection readiness, and fostering a quality culture aligned with R&D and global standards. Acts as a senior quality partner to key stakeholders in drug development, regulatory affairs, and medical affairs, overseeing risk assessments, quality investigations, and audit management. Ensures quality systems (deviation management, CAPA, change control) are effectively implemented across development programs, including CMC and medical affairs activities. Leads inspection readiness efforts and manages responses to regulatory agency inspections (FDA, EMA, etc.). Provides leadership to develop a high-performing, collaborative quality organization and builds future capabilities. Qualifications: Bachelor’s or higher in Life Sciences, Pharmacy, Chemistry, or related field; 15–20+ years in pharma/biotech, with at least 10 in quality roles within development, regulatory, or medical affairs; deep knowledge of GxP, global regulatory frameworks, and inspection management. Preferred: experience in global biopharma, cross-functional leadership, and exposure to novel modalities like biologics or cell/gene therapies. The role reports to the VP, R&D Quality, and involves strategic partnership, inspection management, and quality oversight across the development lifecycle.