Senior Associate Supply Chain Compliance Management (Amgen External Planning)

Overview

Senior Associate, Compliance Management within the External Planning and Delivery Team, leading compliance infrastructure for the External Planning organization supporting Amgen's CMO-sourced products.

What you'll do

• Own and manage all team SOPs (GMP and non-GMP), work instructions, and guiding documents, including periodic reviews, revisions, and lifecycle management.
• Ensure alignment of team procedures with global policies, regulatory requirements, and CMO oversight standards.
• Coordinate cross-functional reviews and approvals of procedural documents and maintain document control and inspection readiness.
• Monitor and report performance metrics (cycle time, aging, on-time closure) and escalate overdue items.
• Monitor and report trending for SOPs, training, regulatory commitments, deviations and change management, and provide leadership with insights and action plans.
• Own and track all team training requirements (GMP and non-GMP), manage completion and drive closure of overdue items.
• Partner with Quality and HR on training curricula and assignment, develop training materials, and support onboarding of new team members.
• 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 for the team, and ensure archival of audit-related records.
• Partner with Quality Assurance to ensure inspection readiness across the External Planning function.
• Own and manage deviations and change control records across AXP supply chain operations, ensuring timely initiation, routing, and closure.
• Monitor adherence to established procedures, identify compliance gaps, and drive process improvements to documentation, training tracking, and governance workflows.
• Support risk assessments and change management activities impacting External Planning.

What you'll need

• Any degree and 5-9 years' supply chain experience in a GMP-regulated pharmaceutical or biotechnology industry, or related business fields.
• At least 2 years' experience working in teams, projects, and programs (may run concurrently with the GMP-regulated experience).
• Strong attention to detail and compliance mindset.
• High level of ownership and accountability.
• Ability to manage multiple priorities in a fast-paced environment.
• Proactive problem-solving skills.
• Strong stakeholder management and collaboration skills.

Nice to have

• 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 systems.
• 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 skills.
• Ability to operate independently while partnering cross-functionally.
• Proficiency in MS Office and document management systems.

Details

• Based at Amgen's Hyderabad site, India; reports to the Business Performance Manager of Supply Planning.