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 seeking someone who can lead change, partnering across the organization matrix on modernization and continuous improvement initiatives to assure 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 assure 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 assure appropriate quality of the pharmaceutical products manufactured and released under the responsibility of CSL Behring AG, Bern.

• 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 in relation to the quality of the pharmaceutical products.
• Lead and have the managerial responsibility for the Site Quality Department and collaborate with all Global Quality Management functions, including Quality Control.

• Ensure the site execution of Global CSL quality strategies.
• Develop, implement and manage supporting local strategies, budget, standards, structure and culture for the CSL Behring AG, Bern Quality department.
• Ensure product and facility compliance with GMP requirements of relevant regulatory bodies in all target markets.
• Provide leadership, management, and support to ensure the implementation and ongoing operation of a functional and effective Quality organization at CSL Behring AG, Bern. This includes a clear definition of responsibilities for Quality Assurance and Batch Release aspects.
• Contribute to the development of interfaces and collaboration between Quality Assurance, Quality Control, Value Streams, Maintenance & Utilities and relevant other functions, e.g. Pharmacovigilance, Regulatory Affairs, and R&D and other parts of the CSL business (CSL Plasma and other manufacturing sites).
• Engage, motivate and develop Site Quality staff and address personnel issues as they arise.
• Ensure adequate resources (budget and headcounts) for efficient quality management in the respective functional areas.
• Review, approve or reject specifications, master manufacturing documents & procedures, sampling instructions, test methods and any other procedures with an impact on product quality (either directly or via delegation to an appropriately qualified and experienced person within the Site Quality department, in collaboration with the respective Value Streams or support functions).
• Ensure establishment of records and their retention according to need and applicable regulations, in collaboration with the respective Value Streams or support functions).
• Ensure the implementation and execution, directly or via appropriate delegation according to CSL's global Quality Management System, of an efficient and effective quality assurance system in all GMP relevant areas to meet regulatory standards in Switzerland and in the target markets for the pharmaceutical products.
• Ensure execution of Management Review of quality performance and Annual Product Reviews / Product Quality Reviews;
• Ensure that cGMP compliance and all factors that may affect product quality are monitored.
• Contribute to drug safety, especially regarding the pharmaceutical quality of drugs, incl. the execution of all necessary measures in case of complaints and possible recalls. Ensures the development of suitable measures for the limitation of possible negative impacts.
• Ensure an adequate inspection management process, this includes adequate preparation to enable a positive execution of national/international regulatory inspections and other third-party audits. Initiates the analysis of the inspection results as well as corrective/preventive actions and ensures that the responses to authorities are provided in a timely manner and the commitments are consistent with operations at other CSL facilities.
• Support R&D product improvement initiatives.
• Represent the company towards authorities (Swissmedic, FDA and other agencies) in all questions relating to the product quality of both investigational and licensed products manufactured at or under the responsibility of CSL Behring AG, Bern.

• 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.
• 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. Prior experience working with plasma derived products and their specific regulations preferred.
• Fluent in English and German