Manager/Senior Manager, GMP Quality - Drug Substance

Role: Manager/Senior Manager, GMP Quality - Drug Substance to oversee QA activities supporting clinical and commercial DS manufacturing, testing, and release. Objectives include ensuring compliance with cGMP standards, inspection readiness, and supporting regulatory audits. Responsibilities encompass managing QA operations for internal and CMO activities, reviewing batch records, deviations, and validation data, and leading inspection support and regulatory interactions. The role involves strategic leadership, oversight of QMS processes, and cross-functional collaboration with Operations, CMC, Regulatory, and Supply Chain teams. Requirements: Bachelor’s in Chemistry, Biological Sciences, Engineering, or related; 5+ years in pharmaceutical QA within cGMP environments; experience with Drug Substance manufacturing and CMO oversight; knowledge of FDA, EMA, ICH regulations; proficiency with SAP and Veeva. Preferred: limited commercial experience, strong analytical and communication skills, ability to manage multiple priorities. HighValue: GMP QA, Drug Substance manufacturing, cGMP compliance, CMO oversight, regulatory inspection support, clinical to limited commercial programs, SAP/Veeva systems. WorkSetup: onsite Carlsbad, CA.