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

Laboratory Animal Management Association

Unterschleißheim, Germany
Qualified person (qp) certification per eu regulation 2019/6
Gmp compliance in sterile pharmaceutical manufacturing
Team leadership of quality operations group
This role combines the technical responsibility of a Qualified Person with genuine leadership duties for a team of seven employees

Job Summary

  • This role combines the technical responsibility of a Qualified Person with genuine leadership duties for a team of seven employees.
  • The position requires ensuring GMP compliance across the entire production value stream while maintaining high visibility on the shop floor.
  • Candidates must possess specific qualification as a Sachkundige Person under Article 97 of EU Regulation 2019/6 to authorize batch releases.

Matching Summary

This role combines the technical responsibility of a Qualified Person with genuine leadership duties for a team of seven employees.

Skills & Requirements

Must-have

  • Qualified Person (QP) certification per EU Regulation 2019/6
  • GMP compliance in sterile pharmaceutical 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
  • Global network collaboration experience
  • Proactive problem-solving approach
  • Hands-on operational presence on shop floor

Key Requirements

  • Qualified Person (QP) qualification per EU Regulation 2019/6
  • Degree in Chemistry, Pharmacy, or Biotechnology
  • Multi-year experience in pharmaceutical industry GMP
  • German and English language proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter