Manager, Commissioning & Qualification (c&q) Document Preparation - Drug Substance

Amgen Inc

Gmp commissioning and qualification experience
C&q documentation preparation including protocols
Leading blended teams of employees and contingent workers
This role leads a blended team responsible for preparing compliant, inspection-ready commissioning and qualification documentation

Job Summary

  • This role leads a blended team responsible for preparing compliant, inspection-ready commissioning and qualification documentation.
  • The position requires partnering with Engineering, Validation, Quality, and Manufacturing teams to ensure operational readiness across multiple sites.
  • Candidates must have 8-13 years of experience in GMP environments with a focus on technical operations and documentation standards.

Matching Summary

This role leads a blended team responsible for preparing compliant, inspection-ready commissioning and qualification documentation.

Skills & Requirements

Must-have

  • GMP commissioning and qualification experience
  • C&Q documentation preparation including protocols
  • Leading blended teams of employees and contingent workers
  • Risk-based qualification methodologies
  • Lifecycle validation approaches

Nice-to-have

  • Strong project management and organizational skills
  • Excellent written and verbal communication skills
  • Continuous improvement initiative contributions
  • Experience with inspection readiness principles

Key Requirements

  • Bachelors or Masters degree
  • 8-13 Years of work experience
  • Experience in GMP commissioning and qualification

Work Rights

Not specified

Tailored Resume

Cover Letter