Supply Chain Compliance Sr Associate AXP

Career Category

Supply Chain

Job Description

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 skill
• 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

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.

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