Qualified Person Als Quality Operations Group Lead Compliance (m/w/d)

29

Unterschleißheim, Germany
Qualified person (qp) certification eu 2019/6
Gmp compliance in sterile manufacturing
Team leadership of quality operations group
The role combines hands-on operational tasks with strategic leadership to ensure global product quality and patient safety

Job Summary

  • The role combines hands-on operational tasks with strategic leadership to ensure global product quality and patient safety.
  • Candidates will lead a team of seven, managing the site's quality system while representing the location in a global network.
  • This position requires ensuring GMP compliance across all value streams including production, packaging, and storage of biopharmaceuticals.

Matching Summary

The role combines hands-on operational tasks with strategic leadership to ensure global product quality and patient safety.

Skills & Requirements

Must-have

  • Qualified Person (QP) certification EU 2019/6
  • GMP compliance in sterile manufacturing
  • Team leadership of Quality Operations group
  • Batch release authority and decision making
  • Deviation management and complaint handling

Nice-to-have

  • Experience with aseptic validation processes
  • Strategic development of quality systems
  • Proactive problem-solving approach
  • International network collaboration experience

Key Requirements

  • QP qualification per Article 97 Abs. 2 and 3 EU Regulation 2019/6
  • Degree in Chemistry, Pharmacy, or related field
  • Multi-year experience in pharmaceutical industry
  • Fluency in German and English languages

Work Rights

Not specified

Tailored Resume

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