Senior Manager Quality Operations Compliance (m/w/d) – Befristet Auf 2 Jahre

Merck & Co., Inc.

Unterschleißheim, Germany
Gmp compliance in sterile manufacturing
Deviation and change control management
Biopharmaceutical industry experience
This role offers the opportunity to lead operational quality projects within a global biopharmaceutical production network while ensuring strict adherence to GMP standards

Job Summary

  • This role offers the opportunity to lead operational quality projects within a global biopharmaceutical production network while ensuring strict adherence to GMP standards.
  • The position involves strategic development of quality systems, managing deviations and change controls, and acting as a Qualified Person for batch release if qualified.
  • Candidates will work closely with production teams to implement 'QA on the shop floor' initiatives, driving continuous improvement and high visibility quality assurance.

Matching Summary

This role offers the opportunity to lead operational quality projects within a global biopharmaceutical production network while ensuring strict adherence to GMP standards.

Skills & Requirements

Must-have

  • GMP compliance in sterile manufacturing
  • Deviation and Change Control management
  • Biopharmaceutical industry experience
  • Operational leadership in matrix structure
  • QA on the shop floor implementation

Nice-to-have

  • Qualified Person qualification preferred
  • Hands-on operational problem solving
  • Strategic quality development skills
  • Global network collaboration experience
  • Aseptic validation support capability

Key Requirements

  • Degree in Chemistry, Pharmacy, or Biotechnology
  • Multi-year pharmaceutical industry experience
  • Knowledge of EU Regulation 2019/6 Article 97
  • Fluency in German and English languages

Work Rights

Not specified

Tailored Resume

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