Head of Compliance (m/f/x) - Deviation Management

at  CSL Behring

For our Value Stream Filling in Marburg we are currently looking for a

EDUCATION & REQUIREMENTS:

• Master 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 including 3+ years’ 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

• Strong leadership while motivating, developing and leading the team according to CSL values and principles.
• Leading/coordination of complex deviations, identifying correct root causes (RC) and smart, effective CAPAs to avoid any re-occurrence of deviations. Compilation of deviation reports and risk assessments ready to be approved by QA.
• Performing data analysis and trending as a tool to identify potential compliance/process issues (e.g. IPC warning limits excursions, drop in yields) in a proactive manner, as a tool to identify potential opportunities for process improvements and/or to understand root causes of more complex compliance/process issues to initiate an appropriate remediation.
• Ensuring optimal inspection readiness in the Value Stream Fill. Preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required
• Maintaining GMP training and adequate training status to ensure a compliant production (cGMP, EHS)
• Might act as compliance representative/SME on behalf of the Value Stream in projects or other initiatives.
• Initiate, coordinate and/or assessment of change controls. Ensure a compliant RTO (release to operation).
• Approval of production protocols according to §14 AMG (German Medicines Act)