Position: cGMP Quality Assurance Manager
About: The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities at a pharmaceutical company. The incumbent is responsible for evaluating internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards. They also monitor Contract Manufacturing Organizations (CMOs) ensuring compliance of the manufacturing, packaging, and analytical testing of pharmaceutical dosage forms and drug substances. The role involves identifying risks and deficiencies, communicating them to cross-functional teams and management.
Requirements: Auditing experience in a GMP and GCP environment; Excipient cGMP production and quality assurance experience; Knowledge of US, EMA, NMPA, PMDA, HC, and ICH regulations, guidance, and industry standards for CMC, GMP, and GCP; 10+ years in pharmaceutical Quality Assurance
Benefits: health insurance, 401(k), flexible work schedule, employee discount on food and beverages, comprehensive health insurance
