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

Mayoly

Unterschleißheim, Germany
Not specified; not specified; not specified
Qualified person (qp) certification eu 2019/6
Gmp compliance in sterile 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 value stream while maintaining high visibility on the production floor.
  • Candidates will represent the site in the global network, manage batch releases, and support regulatory inspections and audits.

Matching Summary

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

Salary

Not specified; Not specified; Not specified

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
  • Hands-on operational presence on shop floor
  • Global network collaboration experience

Key Requirements

  • QP qualification per Article 97 Abs. 2 and 3 EU Regulation 2019/6
  • Degree in Chemistry, Pharmacy, or Biotechnology
  • Multi-year pharmaceutical industry experience
  • Sterile drug manufacturing knowledge
  • German and English language proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter