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

39med

Unterschleißheim, Germany
Not specified; not specified; not specified
Gmp compliance in sterile manufacturing
Deviation management and complaint handling
Change control process execution
This role involves leading quality operations and ensuring all products meet strict GMP standards within a global production network

Job Summary

  • This role involves leading quality operations and ensuring all products meet strict GMP standards within a global production network.
  • The position offers the opportunity to act as a Qualified Person for batch release while managing site-specific quality systems.
  • Candidates will work closely with production teams to implement 'QA on the shop floor' and drive continuous improvement initiatives.

Matching Summary

This role involves leading quality operations and ensuring all products meet strict GMP standards within a global production network.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • GMP compliance in sterile manufacturing
  • Deviation management and complaint handling
  • Change control process execution
  • QA on the shop floor implementation
  • Aseptic validation support

Nice-to-have

  • Qualified Person (QP) qualification experience
  • Hands-on operational leadership style
  • Strategic quality development skills
  • Global network collaboration ability
  • Proactive problem-solving approach

Key Requirements

  • Degree in Chemistry, Pharmacy, or Biotechnology
  • Multi-year pharmaceutical industry experience
  • Sterile drug manufacturing knowledge
  • German and English language proficiency
  • Preferred QP qualification under EU Regulation 2019/6

Work Rights

Not specified

Tailored Resume

Cover Letter