Head of Compliance (m/w/d) - Deviation Management

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

Head of Compliance (m/f/x)

Deviation Management

R-252602

Fulltime / permanent

The job incumbent is a key player in the Value Stream both for critical deviation investigations as well as in internal, customer and regulatory audits. The main responsibility of the role is to proactively drive and improve cGMP compliance and a best in class Right First Time (RFT) approach (deviation and CAPA management, data trending and analysis, training, SOPs, change control) within the respective Value Stream. The role might act as Compliance representative/SME on behalf of the Value Stream in projects or other initiatives. The compliance to relevant Global Quality Policies should be ensured while the respective SOPs and/or working instructions are continuously monitored to be well compliant, if necessary to be revised accordingly.

• Strong leadership while motivating, developing and leading the team according to CSL values and principles.
• Leading and developing a team of approx. 12 motivated and qualified team members
• 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)

• 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