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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