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, based at Amgen’s Hyderabad site, will be a key member of this team and a foundational contributor to the External Planning work center, supporting the business performance and continuous improvement of planning operations. The role requires strong knowledge of GMP environments, document management systems, and cross-functional collaboration within a highly regulated biopharmaceutical supply chain.

Responsibilities:

Compliance & SOP Governance

• 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.

Training Management

• 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.

Regulatory & Audit Support

• 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.

Deviation & Change Control Management

• 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.

Continuous Improvement

• 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.

Key Skills & Competencies

• 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications:

• Any degree and 5-9 years’ supply chain experience in GMP-regulated pharmaceutical / biotechnology industry, or related business fields

In addition to meeting above requirements, you must have at least 2 years’ experience working in teams, projects, and programs. This experience may run concurrently with the required GMP-regulated experience referenced above.

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 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.