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Quality Compliance Senior Manager

United States, Remote 132037.30 - 178638.70 USD / Year · Job Posted April 10, 2026
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Job Description

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.

Job Responsibility

  • End‑to‑End Inspection Process Ownership
  • DQMS Business Ownership
  • Cross‑GxP Inspection Alignment
  • Metrics, Monitoring & Management Review
  • Governance, Compliance & Continuous Improvement

Requirements

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

Nice to have

  • 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

What we offer

  • 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

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