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Head of Compliance
vor 3 Wochen
For our Value Stream **Base Fractionation** Marburg we are looking for a
**Head of Compliance (f/m/d) - R-208811**
(fulltime/ permanent/ non-tariff/ location: Marburg)
Position Purpose
The main responsibility of the role is to drive and maintain Quality Assurance systems to ensure cGMP compliance and a best in class Right First Time (RFT) approach (deviation management, change control, SOPs, training, data trending and analysis) within the respective Value Stream.
The job incumbent is a key player to represent the Value Stream both during critical deviation investigations as well as in internal, customer and regulatory audits. 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.
**Main Responsibilities and Accountabilities**:
- Provides leadership while motivating, developing and leading the team according to CSL values and principles.
- Approval of production protocols according to -14 AMG (German Medicines Act)
- Leads/coordinates complex deviations, identification of the right root cause (RC), identification of smart, effective CAPAs to avoid any re-occurrence of deviations. Compilation of deviation reports and risk assessments ready to be approved by QA.
- Performance of data analysis and trending as a tool to foresee/tackle 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 right to initiate an appropriate remediation.
- Supports preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required and ensure optimal inspection readiness
- The job incumbent is a key player to represent the Value Stream both during critical deviation investigations as well as in internal, customer and regulatory audits.
- Establishes and maintains GMP training, site quality policies, SOPs and practices to ensure a compliant production (cGMP, safety, environmental protection, health care, lean)
- Initiate, coordinate and/or assessment of change controls. Ensure a compliant RTO (release to operation).
- Ensure adequate training status across the respective Value Stream (cGMP compliance, safety and environmental protection)
- Might act as compliance representative/SME on behalf of the Value Stream in projects or other initiatives.
**Position Qualifications and Experience 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 and cGMP compliance 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
**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
**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. Learn more about CSL Behring.
**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Behring**:
