Associate Director, Development Quality – OSD

Role: Provide modality-focused development QA leadership for oral biopharmaceutical programs, ensuring phase-appropriate oversight, risk management, and compliance. Responsibilities: develop program quality strategies, oversee governance, manage readiness milestones, guide the application of QMS processes, and maintain inspection-ready documentation. Partner with CMC and clinical supply teams on control strategies, tech transfer, and issue management, supporting progression toward commercialization. Qualifications: BS in Life Sciences or Engineering; 10–12 years of QA experience in development-stage oversight; strong leadership and risk assessment skills. Preferred: experience in pharmaceutical/biotech oral product development, clinical supply interfaces, and external vendor oversight. High-Value: focus on oral small molecule therapeutics, development phases, inspection readiness, and cross-functional collaboration with CMC and clinical teams. Work setup details are not specified.