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

539

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

Job Summary

  • This role combines hands-on operational tasks with strategic leadership to ensure global product quality and patient safety.
  • The successful candidate will act as the Qualified Person responsible for batch releases while leading a team of seven in compliance operations.
  • The position requires high visibility on the shop floor, close collaboration with production teams, and active participation in GMP inspections.

Matching Summary

This 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 collaboration experience
  • Coaching and team development skills

Key Requirements

  • QP qualification per Article 97 Abs. 2 and 3 of Regulation (EU) 2019/6
  • Degree in Chemistry, Pharmacy, Food Technology, or Biotechnology
  • Multi-year experience in pharmaceutical industry GMP requirements
  • Fluency in German and English languages

Work Rights

Not specified

Tailored Resume

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