Associate Director, Development Quality – OSD

Role: Provide modality-specific QA leadership for oral development programs in biopharma, ensuring phase-appropriate oversight, risk management, and compliance. Responsibilities: develop and execute program quality strategies, oversee external vendors/CMOs, maintain inspection readiness documentation, and support efficient progression toward commercialization in MASH therapeutics. Requirements: BS+ in Life Sciences/Engineering; 10–12 years of QA experience with development-stage oversight, cross-functional 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 modalities within biopharma, development stage (likely clinical), GxP compliance, and inspection readiness. Collaboration involves internal teams and external partners; work setup details unspecified, but implies a senior, leadership role.