Senior Associate Supply Chain Compliance Management (Amgen External Planning)
Core
Lead and maintain compliance infrastructure for the External Planning organization, ensuring GMP and non-GMP documentation, training, and procedural requirements are established and maintained to support operational excellence in a biopharmaceutical supply chain.
Role type
Senior Associate Supply Chain Compliance Management (GMP)
Builds
Reliable, efficient, and agile planning and delivery operations for Amgen's CMO-sourced products
Domain
Biopharmaceuticals / Supply Chain / Quality Compliance
Required skills
GMP knowledge, SOP governance, document control, training management, audit support, deviation and change control management, cross-functional collaboration
Preferred skills
Experience in External Manufacturing or Quality within GMP environment, project management, MS Office proficiency
Technologies
Document management systems, Quality systems
Responsibilities
Own and manage all team SOPs (GMP and non-GMP), Lead periodic SOP reviews and revisions, Support internal and external audits and inspections, Own and manage deviations and change control records, Monitor and report performance metrics and compliance trends
Seniority
Senior, hands-on IC
