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In this vital role you will be part of the External Planning and Delivery Team, which is responsible for strategy and execution of all aspects of supply chain supporting our external manufacturing network. The Senior Associate Amgen External Planning (AXP) reports to the Business Performance Manager of Supply Planning at the Amgen India, Hyderabad site. In this role, the Senior Associate Supply Chain Compliance is responsible for leading and maintaining compliance infrastructure for the External Planning organization ensuring that all GMP and non-GMP documentation, training, and procedural requirements are established, maintained, and continuously improved to support operational excellence. This individual will serve as the compliance lead for the External Supply team, owning Standard Operating Procedures (SOPs), Deviation and Change Controls, training governance, inspection readiness support, and adherence to internal Amgen policies and global regulatory requirements. This role will require a close partnership with Amgen External Supply, Global / Regional / Site Supply Chain, Global Distribution, and External Quality.
Job Responsibility:
Own and manage all team 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 of team procedures 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 (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
Own and track all team training requirements (GMP and non-GMP)
Manage training completion, driving closure of overdue items
Partner with Quality and HR to ensure accurate 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
Ensure proper documentation and 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
Ensure timely initiation, routing, and closure in accordance with procedures and timelines
Maintain accurate, complete, and compliant records within quality systems
Support workflow execution through coordination, tracking, and documentation updates
Ensure audit readiness with complete, accurate, and inspection-ready records
Monitor adherence to established procedures and identify compliance gaps
Drive process improvements to simplify documentation, training tracking, and governance workflows
Support risk assessments and change management activities impacting External Planning
Requirements:
Any degree and 5-9 years' supply chain experience in GMP-regulated pharmaceutical / biotechnology industry, or related business fields
at least 2 years' experience working in teams, projects, and programs (this experience may run concurrently with the required GMP-regulated experience referenced above)
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