Career CategorySupply ChainJob DescriptionSenior Associate, Compliance Management (Amgen External Planning)What you will doLet’s do this! Let’s change the world! In this vital role you will be part of the External Planning and DeliveryTeam, which is responsible for strategy and execution of all aspects of supply chain supporting ourexternal manufacturing network.The Senior Associate Amgen External Planning (AXP) reports to the Business Performance Manager ofSupply Planning at the Amgen India, Hyderabad site. In this role, the Senior Associate Supply ChainCompliance is responsible for leading and maintaining compliance infrastructure for the External Planningorganization ensuring that all GMP and non-GMP documentation, training, and procedural requirementsare established, maintained, and continuously improved to support operational excellence. This individualwill serve as the compliance lead for the External Supply team, owning Standard Operating Procedures(SOPs), Deviation and Change Controls, training governance, inspection readiness support, andadherence to internal Amgen policies and global regulatory requirements. This role will require aclose 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 theExternal Planning work center, supporting the business performance and continuous improvement ofplanning operations. The role requires strong knowledge of GMP environments, document managementsystems, and cross-functional collaboration within a highly regulated biopharmaceutical supply chain.Responsibilities:Compliance & SOP GovernanceOwn 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 changemanagement) trending and provide leadership with insights and action plans forimprovement.Training ManagementOwn 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 SupportSupport internal and external audits and inspections related to External Supply operations and documentation practicesTrack 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 ManagementOwn and manage deviations and change control records across AXP supply chainoperations.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 ImprovementMonitor 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 & CompetenciesStrong attention to detail and compliance mindsetHigh level of ownership and accountabilityAbility to manage multiple priorities in a fast-paced environmentProactive problem-solving skillsStrong stakeholder management and collaboration skillWhat we expect of youWe 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 fieldsIn 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-regulatedPreferred 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..