Senior Associate, Compliance Management (Amgen External Planning)

About the Role Senior Associate, Compliance Management (Amgen External Planning) is part of the External Planning and Delivery Team responsible for strategy and execution of all aspects of supply chain supporting Amgen’s external manufacturing network. The role leads and maintains the compliance infrastructure for External Planning, ensuring GMP and non-GMP documentation, training, and procedural requirements meet regulatory and Amgen standards. Based in Amgen Hyderabad, this position collaborates across External Supply, Global/Regional/Site Supply Chain, Global Distribution, and External Quality to enable compliant, efficient planning and delivery.

What You'll Do

• Own and manage all SOPs (GMP and non-GMP), work instructions, and guiding documents; lead periodic SOP reviews, revisions, and lifecycle management in alignment with Amgen quality systems; ensure alignment with global policies, regulatory requirements, and CMO oversight standards; coordinate cross-functional reviews and approvals; maintain document control and ensure inspection readiness at all times.
• Monitor and report performance metrics (e.g., cycle time, aging, on-time closure); escalate overdue items; monitor and report (SOP, training, regulatory commitments, deviations and change management) trending and provide leadership with insights and action plans for improvement.
• Training Management: Own and track all team training requirements (GMP and non-GMP); manage training completion, tracking, and documentation.

What We're Looking For

• Strong knowledge of GMP environments, document management systems, and cross-functional collaboration within a highly regulated biopharmaceutical supply chain.
• Experience owning SOPs, deviations, change controls, training governance, and inspection readiness.
• Ability to monitor and trend performance metrics and provide actionable insights and action plans for improvement.
• Excellent coordination and communication skills to partner with External Supply, Global / Regional / Site Supply Chain, Global Distribution, and External Quality.