Senior Director, Quality Management for the Bern site
Vor 4 Tagen
We are seeking a quality leader to join our team at CSL Behring AG in Bern, Switzerland. As a Senior Director, Quality Management, you will be responsible for leading change and partnering across the organization to modernize and improve quality initiatives. You will develop and lead the Site Quality function to ensure the quality of pharmaceutical products manufactured and released under the responsibility of CSL Behring AG, Bern.
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 in relation to the quality of pharmaceutical products.
- Lead and have 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.
- Contribute to the development of interfaces and collaboration between Quality Assurance, Quality Control, Value Streams, Maintenance & Utilities, and relevant other functions.
- 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.
- Ensure the establishment of records and their retention according to need and applicable regulations.
- Ensure the implementation and execution 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 the 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.
- Ensure an adequate inspection management process, including adequate preparation to enable a positive execution of national/international regulatory inspections and other third-party audits.
- 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.
Requirements
- 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.
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.
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