Senior Manager Stability

The Stability function is part of the Amgen Product Quality organization, providing governance and management of lean, harmonized, and compliant Stability data packages for all of Amgen’s products. In this team-based role, the Senior Manager Stability will collaborate with Product Quality Teams (PQTs) and the supporting Specialists to ensure the design, management, maintenance, and data analysis of a product’s stability program support GMP compliance and meet the Market Authorization commitments. In this leadership and management role you will provide critical support to PQTs through management of activities and staff supporting stability programs for late-stage clinical and commercial products to ensure PQT deliverables and requirements are met. In this team-oriented leadership role, you will serve as a subject matter expert of commercial product stability and GMP data management strategy, directly adding to the success of PQTs by ensuring support for the commercial product stability programs, collaborating on issue resolutions and investigations, and working closely with diverse functional groups including Supply Chain, Manufacturing, Global CMC Statistics, External Supplier Quality, Quality Control, Regulatory, Quality Assurance, external providers, and other departments on a variety of activities.