Supply Chain Compliance Sr Associate AXP India - Hyderabad

Job title: Supply Chain Compliance Sr Associate AXP India - Hyderabad

About the Role Join Amgen's External Planning and Delivery team as a Senior Associate responsible for establishing and maintaining the compliance infrastructure for External Planning. The role leads GMP and non-GMP documentation, training governance, SOP ownership, deviation and change control, and inspection readiness to support operational excellence across Amgen's external manufacturing network.

What You'll Do

• Own and manage all team SOPs (GMP and non-GMP), work instructions, and guiding documents; lead periodic SOP reviews, revisions, and lifecycle management; ensure alignment with global policies, regulatory requirements, and CMO oversight standards.
• Coordinate cross-functional reviews and approvals of procedural documents; maintain document control and ensure inspection readiness at all times; monitor and report performance metrics and trending; escalate overdue items.
• Manage training requirements (GMP and non-GMP); track training completion and overdue items; partner with Quality and HR to ensure curricula accuracy; develop training materials and support onboarding; prepare compliance dashboards and periodic status reports.
• Support internal and external audits and inspections related to External Supply operations and documentation practices; track and manage compliance commitments, CAPAs, and action items; ensure proper archival of audit records; partner with Quality Assurance for inspection readiness.
• Own and manage deviations and change control records across AXP supply chain operations; ensure timely initiation, routing, and closure; maintain accurate, complete, and compliant records; support workflow coordination and documentation updates; ensure audit readiness.
• Drive continuous improvement by monitoring adherence to procedures, identifying compliance gaps, and simplifying documentation, training tracking, and governance workflows; support risk assessments and change management activities.

What We're Looking For

• Basic Qualifications: Any degree and 5-9 years’ supply chain experience in GMP-regulated pharmaceutical/biotechnology industries; at least 2 years’ experience working in teams, projects, and programs.
• Preferred Qualifications: Experience in Supply Chain, External Manufacturing, or Quality within a GMP environment; strong knowledge of GMP documentation practices and quality systems; experience managing SOPs and document control; familiarity with document management systems and training compliance tracking; experience supporting audits or regulatory inspections; strong organizational and project management skills; excellent written and verbal communication; ability to operate independently while partnering cross-functionally; proficiency in MS Office and document management systems.

Nice to Have

• Experience with External Supply / AXP or CMO-sourced products; familiarity with inspection readiness and regulatory environments.