Mqa Manager Sterile Filling (m/w/d)

Roche

Mannheim, Germany
Gmp-compliant batch release
Deviation and capa management
Lean-mindset culture implementation
You support patient care by ensuring GMP-compliant and timely release of pharmaceutical batches while adhering to legal, regulatory, and internal Roche requirements

Job Summary

  • You support patient care by ensuring GMP-compliant and timely release of pharmaceutical batches while adhering to legal, regulatory, and internal Roche requirements.
  • You actively promote the Lean-Mindset culture and continuous process harmonization and improvement within sterile drug product manufacturing.
  • You take on operational and strategic GMP coaching responsibilities and represent quality aspects locally and globally, including audit participation and regulatory interactions.

Matching Summary

You support patient care by ensuring GMP-compliant and timely release of pharmaceutical batches while adhering to legal, regulatory, and internal Roche requirements.

Skills & Requirements

Must-have

  • GMP-compliant batch release
  • Deviation and CAPA management
  • Lean-Mindset culture implementation
  • Sterile drug product manufacturing
  • Quality audits and self-inspections
  • Multisite quality coordination

Nice-to-have

  • GMP coaching and mentoring
  • Agile team collaboration
  • Technical/IT understanding
  • Cross-functional teamwork
  • Bilingual communication German and English

Key Requirements

  • Master's degree in scientific field
  • 3-5 years experience with PhD or 5-7 years with Master/Diploma
  • Expertise in sterile pharmaceutical manufacturing
  • Knowledge of EU GMP Annex 1
  • Experience in deviation and CAPA processes
  • Fluent German and English communication

Work Rights

Not specified

Tailored Resume

Cover Letter