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

Laboratory Animal Management Association

Unterschleißheim, Germany
Not specified; not specified; not specified
Gmp compliance in sterile manufacturing
Deviation and complaint management
Change control process execution
The role involves leading projects within a matrix structure to ensure all materials meet strict quality standards and regulatory requirements

Job Summary

  • The role involves leading projects within a matrix structure to ensure all materials meet strict quality standards and regulatory requirements.
  • Candidates may perform duties as a Qualified Person, including batch release and representation during regulatory inspections.
  • The position requires high visibility on the shop floor with close collaboration between production, quality control, and other departments.

Matching Summary

The role involves leading projects within a matrix structure to ensure all materials meet strict quality standards and regulatory requirements.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • GMP compliance in sterile manufacturing
  • Deviation and complaint management
  • Change control process execution
  • Site quality system leadership
  • Aseptic validation support

Nice-to-have

  • Qualified Person qualification experience
  • Hands-on operational approach
  • Strategic global network collaboration
  • Proactive problem-solving mindset
  • Continuous improvement initiatives

Key Requirements

  • Degree in Chemistry, Pharmacy, or Biotechnology
  • Multi-year pharmaceutical industry experience
  • Knowledge of GMP for sterile products
  • Preferred: Qualified Person qualification per EU Regulation 2019/6
  • Fluency in German and English

Work Rights

Not specified

Tailored Resume

Cover Letter