Quality Compliance Senior Manager

Amgen UK

132,037.30usd -178,638.70 usd py
Gmp/gdp inspection lifecycle governance
End-to-end inspection process ownership
Dqms operations inspection module business ownership
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

Job Summary

  • 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.
  • 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.
  • Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

Matching Summary

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.

Salary

132,037.30USD -178,638.70 USD

Skills & Requirements

Must-have

  • GMP/GDP inspection lifecycle governance
  • end-to-end inspection process ownership
  • DQMS Operations Inspection module business ownership
  • global inspection metrics control plan
  • cross-GxP inspection alignment

Nice-to-have

  • passion for challenges
  • collaborative, innovative, science-based culture
  • industry benchmarking and research
  • effective stakeholder engagement

Key Requirements

  • Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience
  • Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience
  • Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience
  • Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience
  • High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience
  • Prior experience leading or governing GMP/GDP inspections
  • Deep knowledge of global health authority inspection expectations

Work Rights

Not specified

Tailored Resume

Cover Letter