Amgen
biotechnology
SeniorAssociateSupplyChainComplianceManagement(AmgenExternalPlanning)
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“Senior Associate Supply Chain Compliance Management (Amgen External Planning) at Amgen. Skills: Supply Chain Compliance Management, External Planning, GMP and non-GMP documentation, training governance, Standard Operating Procedures (SOPs), Deviation and Change Controls, inspection readiness support, global regulatory requirements, document management systems, SOP lifecycle management, quality systems. Leading and maintaining compliance infrastructure for the External Planning organization. Ensu”
What You'll Achieve.
Ensuring that all GMP and non-GMP documentation, training, and procedural requirements are established, maintained, and continuously improved to support operational excellence; Ensuring alignment of team procedures with global policies, regulatory requirements, and CMO oversight standards; Ensuring inspection readiness at all times; Driving closure of overdue items; Ensuring timely initiation, routing, and closure in accordance with procedures and timelines; Ensuring audit readiness with complete, accurate, and inspection-ready records; Driving process improvements to simplify documentation, training tracking, and governance workflows
Industry & Context.
Proactive problem-solving skills
What They're Looking For.
Must Have
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
Nice to Have
Experience in Supply Chain, External Manufacturing, or Quality within a GMP environment, 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, 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
What You'll Do.
Leading and maintaining compliance infrastructure for the External Planning organization
Ensuring that all GMP and non-GMP documentation
and procedural requirements are established
and continuously improved
Serving as the compliance lead for the External Supply team
Owning Standard Operating Procedures (SOPs)
Deviation and Change Controls
inspection readiness support
and adherence to internal Amgen policies and global regulatory requirements
Managing all team SOPs (GMP and non-GMP)
and guiding documents
Leading periodic SOP reviews
and lifecycle management
Ensuring alignment of team procedures with global policies
regulatory requirements
and CMO oversight standards
Coordinating cross-functional reviews and approvals of procedural documents
Maintaining document control and ensuring inspection readiness
Monitoring and reporting performance metrics (e. g.
on-time closure); escalating overdue items
Monitoring and reporting (SOP
regulatory commitments
deviations and change management) trending and providing leadership with insights and action plans for improvement
Owning and tracking all team training requirements (GMP and non-GMP)
Managing training completion
driving closure of overdue items
Partnering with Quality and HR to ensure accurate training curricula and assignment
Developing training materials and supporting onboarding of new team members
Preparing compliance dashboards and periodic status reports
Supporting internal and external audits and inspections related to External Supply operations and documentation practices
Tracking and managing compliance commitments
and action items for the team
Ensuring proper documentation and archival of audit-related records
Partnering with Quality Assurance to ensure inspection readiness across the External Planning function
Owning and managing deviations and change control records across AXP supply chain operations
Ensuring timely initiation
and closure in accordance with procedures and timelines
and compliant records within quality systems
Supporting workflow execution through coordination
and documentation updates
Ensuring audit readiness with complete
and inspection-ready records
Monitoring adherence to established procedures and identifying compliance gaps
Driving process improvements to simplify documentation
and governance workflows
Supporting risk assessments and change management activities impacting External Planning
How You'll Work.
Team & Collaboration
Close partnership with Amgen External Supply, Global / Regional / Site Supply Chain, Global Distribution, and External Quality; Coordinate cross-functional reviews and approvals of procedural documents; Partner with Quality and HR to ensure accurate training curricula and assignment; Partner with Quality Assurance to ensure inspection readiness across the External Planning function; Ability to operate independently while partnering cross-functionally
Communication Scope
Excellent written and verbal communication skills
Process & Methodology
organizational and project management skills
Full Job Description
## **Career Category** Supply Chain ## ## **Job Description** **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. **Senior Associate, Compliance Management (Amgen External Planning)** ## **What you will do** Let’s do this! Let’s change the world! 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. AXP is a critical component of Amgen’s Global Supply Chain, responsible for enabling reliable, efficient, and agile planning and delivery operations for Amgen’s CMO-sourced products. The Senior Associate, bas
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