Quality Compliance Senior Manager

Amgen

Base: 132,037.30usd -178,638.70 usd; bonus/equity:...
Gmp/gdp inspection lifecycle governance
Global process ownership
Regulatory commitment tracking
This role 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

Job Summary

  • This role 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.
  • As business owner for the DQMS Operations Inspection module, you will be accountable for functional requirements, lifecycle management, data integrity, usability, and ongoing enhancements.
  • Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.

Matching Summary

This role 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.

Salary

Base: 132,037.30USD -178,638.70 USD; Bonus/Equity: Discretionary annual bonus program; Benefits: Comprehensive employee benefits package

Skills & Requirements

Must-have

  • GMP/GDP inspection lifecycle governance
  • Global process ownership
  • Regulatory commitment tracking
  • DQMS Operations Inspection module
  • Cross-GxP inspection alignment

Nice-to-have

  • Industry benchmarking and research
  • GenAI tools usage
  • Collaborative and science-based culture

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