Sr. Mgr External Quality

Job description

Career Category Quality Job Description: Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain etc. Serve as the main Quality point of contact for deviations, change controls,, CAPAs author and revision of quality agreements and batch disposition etc. related to Amgen product. Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements. Review completed production batch records as necessary and approve master batch records, and other cGMP documents from CMOs / Contract Laboratories. Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs. When necessary, facilitate communication regarding deviations, change controls, complaints and batch disposition between the CMO and Amgen staff members. Meet with Quality, Production, Regulatory, and Logistics personnel at the CMO sites as necessary or during regularly scheduled meetings for issues relating to Amgen products. Represent Quality and quality activities from the CMO site on Amgen pr...