Senior Associate Supply Chain Compliance Management

Responsibilities

• Lead and maintain compliance infrastructure for the External Planning organization, ensuring all GMP and non-GMP documentation and training requirements are met
• Own and manage the lifecycle of team SOPs, work instructions, and guiding documents in alignment with quality systems
• Manage training governance, including tracking requirements, driving completion, and developing training materials
• Oversee deviation and change control records, ensuring timely initiation, routing, and closure
• Support internal and external audits and inspections by maintaining inspection readiness and managing compliance commitments
• Monitor and report performance metrics and compliance trending to provide leadership with actionable insights
• Drive continuous improvement by identifying compliance gaps and simplifying documentation and governance workflows

Requirements

• 5-9 years of supply chain experience in a GMP-regulated pharmaceutical or biotechnology industry
• At least 2 years of experience working within teams, projects, or programs
• Strong knowledge of GMP documentation practices and quality systems
• Proven experience in SOP and document control management

Preferred Qualifications

• Experience in Supply Chain, External Manufacturing, or Quality within a GMP environment
• Familiarity with document management systems and training compliance tracking
• Experience supporting regulatory inspections or audits
• Strong organizational, project management, and stakeholder management skills
• Proficiency in MS Office and ability to operate independently in a cross-functional environment

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients suffering from serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen discovers, develops, and delivers innovative human therapeutics to millions of patients worldwide.