Senior Manager, GMP Investigational Quality

Role: Senior Manager, GMP Investigational Quality, overseeing GMP compliance and lot release activities for early and late-stage clinical programs at Syndax Pharmaceuticals. Responsibilities: review and approve GMP documentation such as batch records, certificates of analysis, and specifications; support clinical release activities including labeling, packaging, and stability; collaborate with external CMOs, labs, and internal teams to ensure manufacturing, testing, and distribution adhere to cGMPs and regulatory standards; lead investigations into quality deviations, CAPAs, OOS/OOT events, and product impact assessments; identify GMP risks and drive process improvements; author and review GMP quality documents; maintain clear communication on quality status and issues. Requirements: BS in a scientific field; at least 5 years’ GMP experience supporting contract manufacturing and clinical-stage programs; strong knowledge of GMP review processes for drug substances, products, and finished goods; experience managing deviations, investigations, and cross-functional teams; excellent technical writing and communication skills; ability to operate independently in a fast-paced, outsourced environment. High-Value: GMP oversight for clinical drug substance, drug product, and finished goods; experience supporting early phase clinical programs; cross-functional collaboration with CMC, Analytical Development, Supply Chain, Regulatory Affairs; experience with manufacturing, packaging, labeling, stability, and release activities. Location: New York, NY; hybrid work possible; no travel specified.