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Senior Quality Associate – Global Pathogen Safety

CSL BehringBern, Berne, Switzerland

Salary not disclosed

Research DevelopmentFull Time
English

Innovative and committed to patients worldwide. CSL Behring is a global biotechnology leader, driven by its promise to save lives. At our site in Bern, our employees develop and manufacture life-saving therapies for people with serious and rare diseases around the world. For our Global Pathogen Safety (GPS) organization in Bern, we are looking for an experienced quality professional to join us as Senior Quality Associate – Global Pathogen Safety (100%) (m/f/d) In this role, you will provide Quality Assurance oversight for our Global Pathogen Safety laboratories and help ensure that laboratory and research activities are conducted in accordance with applicable quality and regulatory requirements. You will work closely with laboratory teams, study personnel and other stakeholders to maintain and continuously improve our quality systems, support inspection readiness and foster a strong and proactive quality culture. Your primary focus will be on compliance with the OECD Principles of Good Laboratory Practice (GLP), GCLP (ISO/IEC 17025) and CSL's Good Research Laboratory Practice (GRLP) standards. Depending on business needs, you may also provide quality oversight for nonclinical development activities within Research EU and support biosecurity and biosafety compliance at the Bern site. Responsibilities Provide Quality Assurance oversight for Global Pathogen Safety laboratory activities and ensure compliance with applicable GLP, GCLP/ISO 17025, GRLP and internal CSL requirements. Establish, maintain and continuously improve quality procedures, standards and systems in collaboration with laboratory teams and other stakeholders. Review study plans, protocols and reports for GLP compliance and prepare Quality Assurance statements for final study reports. Plan and conduct process, facility, study and document inspections in accordance with GLP and GRLP requirements, document findings and follow up on resulting actions. Communicate inspection results and quality-related obse

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