Senior Director, Quality Management for the Bern site fluent in English and German
Vor 3 Tagen
We are seeking a quality leader for our plasma fractionation and finished dosage form manufacturing site located in Bern, Switzerland. For this role, we are looking for someone who can lead change, partnering across the organization matrix on modernization and continuous improvement initiatives to ensure sustainable compliance and operational efficiencies. The successful candidate will be able to thrive in a fast-paced environment while collaborating with local and global colleagues to ensure the long-term, sustained future for the Bern site.
In this role and in line with CSL's Global Quality strategy, you will develop and lead the Site Quality function for CSL Behring AG, Bern, to ensure the appropriate quality of the pharmaceutical products manufactured and released under the responsibility of CSL Behring AG, Bern.
Key responsibilities include:
- Aligning with the Decision Support Lead Quality & Technical Responsible Person to ensure all requirements of the FvP are met.
- Collaborating with Global Clinical Safety and Pharmacovigilance to monitor and control drug safety in relation to the quality of the pharmaceutical products.
- Leading and having managerial responsibility for the Site Quality Department and collaborating with all Global Quality Management functions, including Quality Control.
As a member of the Bern Leadership Team, you will apply CSL's global Quality standards and practices within the local Pharmaceutical Quality System and enforce their implementation at CSL Behring AG, Bern.
Key qualifications:
- Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) or medicine or comparable education; advanced degree preferred.
- 12 years' experience working with GMPs across the pharmaceutical industry, including leadership/team management experience. Operations or quality oversight experience in sterile product manufacture and filling is preferred.
- 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. Prior experience working with plasma-derived products and their specific regulations preferred.
- Fluent in English and German.
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.
Why work at CSL Behring:
We encourage you to make your well-being a priority. It's essential and so are you. Learn more about how we care at CSL.
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