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    Job · 11149447

    Amgen logo

    Supply Chain Compliance Sr Associate AXP

    Amgen · Hyderabad · onsite · Posted 71d ago

    Undisclosed2–7 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Senior Associate, Compliance Management (Amgen External Planning)
    What you will do
    Lets do this! Lets 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 Amgens Global Supply Chain, responsible for enabling reliable, efficient,
    and agile planning and delivery operations for Amgens CMO-sourced products. The Senior Associate,
    based at Amgens 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.

    Sourced from naukri

    Skills

    Writingenvironmentsupply planningDocument Management SystemQuality SystemsProject ManagementTeamworkGMPSupply ChainCommunication SkillsStakeholder ManagementoperationsDocumentationMS Office

    About Amgen

    Amgen logo

    Amgen

    Biotechnology

    1.5k+

    employees

    1980

    46 years old

    Hyderabad, Telangana

    India

    About

    Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.

    Industries

    BiotechnologyBiotech & Life sciences

    Employee ratings

    173 reviews

    2.8/ 5

    Culture

    2.7

    Career growth

    2.5

    Work-life

    2.8

    Employees rate it well for

    Senior Management11Salary7Work Culture7Work Life Balance7Learning6

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    Supply Chain Compliance Sr Associate AXP · waiting for your command