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

Merck & Co., Inc.

Unterschleißheim, Germany
Not specified; not specified; not specified
Gmp requirements in sterile drug manufacturing
Deviation management and complaint handling
Change control process execution
This role involves the operational and technical leadership of projects within a matrix organization to ensure strict quality standards are met

Job Summary

  • This role involves the operational and technical leadership of projects within a matrix organization to ensure strict quality standards are met.
  • The position offers the opportunity to perform tasks as a Qualified Person, including ensuring batch releases and supporting regulatory inspections.
  • The company aims to be the world's most reliable manufacturer of biopharmaceuticals, relying on a global production network to serve patients.

Matching Summary

This role involves the operational and technical leadership of projects within a matrix organization to ensure strict quality standards are met.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • GMP requirements in sterile drug manufacturing
  • Deviation management and complaint handling
  • Change control process execution
  • Aseptic validation support
  • Matrix structure project leadership

Nice-to-have

  • Qualified Person (QP) qualification experience
  • Hands-on operational problem solving
  • Strategic quality development mindset
  • Global network collaboration skills
  • Continuous improvement initiative drive

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 required

Work Rights

Not specified

Tailored Resume

Cover Letter