Teams at Cogent Biosciences

Provide scientific and technical leadership for GMP QC operations supporting clinical and commercial small-molecule programs. Lead method transfer, validation, lifecycle management, release and stability testing, investigations (OOS/OOT), CAPAs, oversight of external labs/CMOs, regulatory support, documentation, and continuous improvement. Mentor junior staff and collaborate cross-functionally to ensure compliant, efficient QC activities.

Lead GCP quality assurance for clinical development, plan and conduct GCP audits of sites/CROs/vendors, ensure inspection readiness, manage deviations/CAPAs, maintain quality systems, support regulatory submissions, and mentor junior QA staff.