Head of Compliance

Vor 3 Tagen

Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit
{"h2": "Head of Compliance Role Overview"}

CSL Behring is seeking a highly skilled and experienced Head of Compliance to join our team in Marburg. As a key player in the Value Stream, you will be responsible for driving and improving cGMP compliance and a best-in-class Right First Time (RFT) approach within the respective Value Stream.

Key Responsibilities
  • Proactively drive and improve cGMP compliance and RFT approach within the Value Stream.
  • Lead complex deviations, identify root causes, and implement effective CAPAs to prevent re-occurrence.
  • Perform data analysis and trending to identify potential compliance/process issues and opportunities for process improvements.
  • Ensure optimal inspection readiness in the Value Stream Fill and prepare for regulatory inspections, self-inspections, and customer audits.
  • Maintain GMP training and ensure a compliant production environment.
  • Act as compliance representative/SME on behalf of the Value Stream in projects or other initiatives.
  • Initiate, coordinate, and assess change controls to ensure a compliant RTO.
Requirements
  • Master's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry).
  • 5+ years of professional experience in the pharmaceutical/biotech industry with specific knowledge in Quality, cGMP compliance, deviation management, and aseptic processes.
  • 3+ years of leadership/team management experience.
  • Proofed experience in occupational safety and continuous improvements methods.
  • Experienced in inspection situations with authorities (e.g., US FDA, Local German Health Authorities/Regierungspräsidium).
  • A Lean Six Sigma Green Belt training is favorable.
About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.

Do work that matters at CSL Behring

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