Manager/Senior Manager, GMP Quality - Drug Substance

Role: Manager/Senior Manager, GMP Quality - Drug Substance, providing QA oversight for clinical and commercial DS manufacturing and testing. Objectives include ensuring cGMP compliance, inspection readiness, and quality system effectiveness. Responsibilities: lead QA activities supporting manufacturing/testing, oversee batch record review, deviations, investigations, CAPAs, change control, and validation; manage external CMOs, support regulatory inspections, and drive continuous improvement. Requirements: Bachelor's in Chemistry, Biological Sciences, Engineering, or related; 5+ years in pharmaceutical QA within cGMP, experience supporting Drug Substance manufacturing, and familiarity with global regulations (FDA, EMA, ICH). Preferred: experience with SAP, Veeva, and supporting both clinical and limited commercial stages. High-value: focus on Drug Substance QA, cGMP compliance, external CMO oversight, regulatory inspection support, and cross-functional collaboration with Technical Operations, CMC, Regulatory, and Clinical teams. Work setup: not specified; likely hybrid or onsite based on typical industry practices.