Senior Director Quality

Role: Senior Director of Quality leading and developing Sagimet Biosciences' Quality Management System (QMS) to support both clinical and commercial product manufacturing. Responsibilities: oversee GxP compliance, develop and maintain SOPs, policies, and quality procedures aligned with ICH, FDA, EMA standards; lead internal audits, regulatory inspections, and manage CAPAs; provide quality oversight for external manufacturing of drug substance and drug product, including vendor qualification, batch review, validation, and stability programs; support CMC development and manufacturing readiness for clinical phases and commercialization; and collaborate cross-functionally with Manufacturing, Regulatory, Clinical Operations, Supply Chain, and Program Management. Leadership duties include shaping the 3-5 year Quality Plan, mentoring staff, managing budgets and vendor relationships, and representing quality in executive forums. Requirements: Bachelor's in a scientific discipline (e.g., Chemistry, Biology) with 12–15 years in pharmaceutical/biotech quality roles, including 5+ years in senior leadership; experience supporting clinical programs (Phase I-III) through regulatory filings; proven expertise in Quality Systems, CMC, and manufacturing (small molecules or biologics); hands-on CMO management; deep knowledge of FDA GMP regulations and ICH guidelines; and experience leading regulatory inspections. Preferred: background in biologics, gene, or cell therapies, and building quality organizations from scratch. Travel: 10–20%. This high-impact role reports to the VP, Technical Operations.