[Hiring] Quality Compliance Senior Manager @Amgen

Role Description

Join Amgen’s Mission of Serving Patients. As part of the GxP Quality Management System (QMS) architecture, the GMP/GDP Inspections Global Process Owner (GPO) leads the design, governance, and continuous advancement of the end‑to‑end GMP/GDP inspection lifecycle, from inspection readiness and preparation through inspection execution, outcome management, and regulatory commitment tracking.

This role is a critical leader within the Inspection Lifecycle Management organization, ensuring consistent, compliant, and inspection‑ready practices across the global network for Health Authority, Notified Body and Business Partner inspections of Amgen.

This role is accountable for establishing and maintaining a robust, globally harmonized inspection framework aligned with applicable regulatory requirements and industry standards, while enabling effective execution at the site and enterprise levels.

Primary Responsibilities:

• End‑to‑End Inspection Process Ownership:
  • Owns the end‑to‑end GMP/GDP inspection process, including inspection preparation, conduct, response development, commitment tracking, and closure.
  • Ensures standardized governance, roles, and controls are in place to support consistent execution of inspections across sites and regions.
  • Leads continuous improvement of inspection processes through lessons learned, inspection trends, and feedback from health authority interactions.
  • Provides global process leadership during GMP/GDP inspections, supporting sites and enterprise stakeholders through inspection activities and regulatory interactions.
• DQMS Business Ownership:
  • Serves as business owner for the DQMS Operations Inspection module, with accountability for:
    • Functional requirements and lifecycle management.
    • Data integrity, usability, and process alignment.
    • Ongoing enhancements to support inspection execution, outcome tracking, and reporting.
  • Partners with QMS, Digital, IT, ILM and Site stakeholders to ensure the module effectively supports global and site‑based inspection activities.
• Cross‑GxP Inspection Alignment:
  • Acts as primary liaison with GCP, GLP, and GPvP Inspection Process Owners to establish consistency and alignment across inspection lifecycle elements where appropriate.
  • Ensures inspection practices, metrics, and governance models are harmonized across GxP domains while respecting regulatory and operational differences.
• Metrics, Monitoring & Management Review:
  • Establishes, maintains, and governs a global inspection metrics control plan, including:
    • Inspection readiness indicators.
    • Inspection outcomes and trends.
    • Commitment timeliness and effectiveness.
  • Owns data capture, maintenance, and integrity for inspection metrics supporting global and site‑based management reviews.
  • Supports ILM teammates for maintenance of site based inspection readiness dashboards.
• Governance, Compliance & Continuous Improvement:
  • Oversees inspection‑related standards, policies, procedures, and guidance documents within the QMS.
  • Leads gap assessments to new regulatory requirements and ensures alignment to regulatory commitments and inspection findings.
  • Partners with Learning & Development to define inspection‑related training content and capability‑building strategies.
  • Performs industry benchmarking and research to identify best practices, emerging trends, and enabling technologies, ensuring alignment with Quality governance expectations, including appropriate use of GenAI tools.
  • Collaborates across Regulatory Compliance, IDQ, ESQ, PAQ, R&D and other functional organizations to maintain and improve the end to end GMP/GDP inspection lifecycle processes.

Qualifications

• Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
• Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
• Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
• Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR
• High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector

Requirements

• Prior experience leading or governing GMP/GDP inspections and regulatory interactions
• Deep knowledge of global health authority inspection expectations and inspection lifecycle management
• Experience owning or governing digital quality systems supporting inspections and regulatory commitments
• Ability to operate strategically and tactically in a complex, global environment
• Strong stakeholder engagement and executive communication skills
• Demonstrated capability in driving operational excellence and continuous improvement across enterprise Quality processes
• In order for the most productive global collaborations, ideal candidate would be based within a U.S. or Western European timezones
• Travel would be limited to ad hoc workshops only if necessary for process or system improvements

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible