Group Head Compliance (female/male) (gdańsk / Duchnice)

rezonbio

Duchnice, Poland
On-site
Compliance governance framework
Regulatory inspections and audits
Quality systems management
Lead the execution of Rezon Bio’s quality and compliance governance framework across both sites

Job Summary

  • Lead the execution of Rezon Bio’s quality and compliance governance framework across both sites.
  • Coordinate and support regulatory inspections (for example EMEA, FDA) and customer audits.
  • Serve as the ultimate compliance contact for customer audits and queries.

Matching Summary

Lead the execution of Rezon Bio’s quality and compliance governance framework across both sites.

Skills & Requirements

Must-have

  • Compliance governance framework
  • Regulatory inspections and audits
  • Quality systems management
  • Risk and issue management
  • Cross-site alignment

Nice-to-have

  • Mission-driven culture
  • Innovation-driven work environment
  • Strategic leadership role

Key Requirements

  • Master's or PhD in biology, pharmacy, biotechnology, chemistry, chemical engineering, medicine, or related
  • Minimum 15 years in pharmaceutical / biotech manufacturing
  • 2 years in quality control or assurance
  • Deep knowledge of GMP and pharmaceutical regulations
  • Proven experience with FDA and EMA inspections
  • Very good working knowledge of English language

Work Rights

Not specified

Tailored Resume

Cover Letter