Senior Director, Quality Management for the Bern Site
vor 1 Tag
We are seeking a quality leader to drive change and modernization initiatives at our plasma fractionation and finished dosage form manufacturing site in Bern, Switzerland. The successful candidate will partner across the organization matrix to ensure sustainable compliance and operational efficiencies.
In this role, you will develop and lead the Site Quality function for CSL Behring AG, Bern, to ensure the quality of pharmaceutical products manufactured and released under our responsibility. You will collaborate with Global Clinical Safety and Pharmacovigilance to monitor and control drug safety.
Key Responsibilities:
- Align with the Decision Support Lead Quality & Technical Responsible Person to ensure all requirements of the FvP are met.
- Collaborate with Global Clinical Safety and Pharmacovigilance to monitor and control drug safety.
- Lead and manage the Site Quality Department and collaborate with all Global Quality Management functions, including Quality Control.
Requirements:
- Degree in a relevant scientific discipline or medicine or comparable education; advanced degree preferred.
- 12 years' experience working with GMPs across the pharmaceutical industry, including leadership/team management experience.
- Should meet the CH requirements for the local Responsible Person (Fachtechnisch verantwortliche Person, FvP).
- Direct experience interacting with global regulatory authorities.
- Change agent with demonstrated record of success in achieving quality objectives.
- Demonstrated success in project management and business/QA system.
- Experience managing within a global matrix organization.
- Advanced knowledge of appropriate regulatory requirements including GMP/GDP.
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 value diversity and inclusion:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. We believe that a diverse and inclusive workplace is essential to our success.
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