Quality Audit Management Lead

vor 17 Stunden

St Gallen, Schweiz CSL Behring Vollzeit

We are currently looking for a Quality Audit Management Lead to join our team in St. Gallen. In this position you will have overall responsibility & accountability for the oversight and management of CSL Vifor GxP Quality Assurance audit programs including GMP, GDP, and Clinical, Medical, Regulatory & Safety (CMRS) aspects in line with existing regulations. You will be accountable for the inspection management and the management of the supplier qualification process including audit planning, conducting and reporting of annual performance review of third-party services. You will be directly reporting to the Head of Quality Assurance & CMRS and will be responsible for leading a small team.

**Key Tasks**
- Oversight of GXP audit planning and execution
- Lead Auditor for GMP-/ GDP external / internal audits
- Management of self-inspection lead auditor group
- Host of GMP- HA/RA and customer inspection/audits
- Reflect regulatory standards on audit management process and third party management process
- Ensure completion of all required third party vendor qualification processes and performance reviews
- Confirmation of management and closure of audit related CAPAs according to global/local standards
- Management and assessment of third party audit vendors and consultants
- Ensure that all audit records are updated and maintained in Trackwise, including related CAPA

**Qualifications**

**Minimum Requirements**
- Minimum of 8 years overall experience within the pharmaceutical, biotechnology industry or CMO
- Preferably 5 years‘ experience in a Quality Assurance role, ideally with supervisory/management experience including global and/or regional audit responsibility
- Proven track record in managing external service providers (CMO)
- Fluency in English and good level of German
- Excellent Communication Skills

**Preferred Requirements**
- Masters Degree in Natural Sciences
- Lean six sigma/ Operational excellence qualification/experience
- Experience of managing/interacting with global stakeholders

**Our Benefits**:
We offer a full range of medical/dental/vision, financial, and other benefits, including 401(k) eligibility and various paid time off benefits, such as vacation, holidays, sick time, and parental leave.

**About CSL Vifor**:
CSL Vifor 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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Vifor**:

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