Senior Manager Quality Compliance External Affairs

Job description

Career Category Quality Job Description: Role Name: Senior Manager Quality Compliance Ex Role Description: The Senior Manager Quality Compliance External Affairs will enhance quality, compliance, and regulatory flexibility by providing leadership and support of external activities impacting Amgen’s Operations function with link to Regulatory Affairs-CMC, with a regional focus on Japan & Asia Pacific (JAPAC). This role will shape, coordinate and provide input in the development of policy, regulatory requirements, and expectations consistent with Amgen’s position and priorities on GMP/GDP primarily in JAPAC and regarding related international organizations (e.g., APEC, ICH, Pharmacopoeias, PIC/S, WHO) in support for GCP, GLP, GPvP compliance, as requested. The senior manager will explain global regulatory and GxP compliance requirements incl. supply chain and trade, focus on regulations and guidance on GMP/GDP/GSP in JAPAC. External: - Business Improvement - Representing Amgen in industry trade (e.g., IFPMA, EFPIA, PhRMA, RDPAC), individual based associations (e.g., PDA, ISPE) and/or academia (e.g., universities, educations institutions) - Networking with peers from other companies (...