Quality Assurance Senior Scientist

Innovative and committed to patients worldwide. CSL Behring is a leading global biotech company committed to its promise to save lives. In Bern, with over 1'600 employees, we develop and distribute life-saving therapies for people with severe and rare diseases worldwide. For the Quality Assurance Division in the Filling area, we are looking for as of 1 August 2026 or by arrangement a Quality Assurance Senior Scientist (100%) - (m/f/d) (fixed-term until 30.09.2028) The quality of our products and especially the well-being of our patients are the priority. Our group reviews the aseptic working methods and the hygiene status in the filling plants, thereby ensuring that the filling of the open product into sterile vials takes place under germ-free conditions. Competencies and responsibilities • Support and advice for aseptic production and microbiological laboratories in quality-relevant questions (no performance of activities within manufacturing or the laboratory). • Review and ensuring compliance with GMP requirements in production as well as supporting operations groups with compliance and risk assessments. • Independent processing and coordination of deviations, including evaluation of root cause analyses, definition of suitable CAPAs, and assessment regarding compliance and risk assessment. • Management of changes in the field of aseptic filling as well as support in the implementation of regulatory requirements and process improvements. • Review and approval of production documentation, environmental monitoring data, and other GMP-relevant documents. • Support in the preparation, execution, and follow-up of internal and external audits as well as regulatory inspections. • Creation and review of quality-relevant documents, SOPs, as well as official statements and responses to regulatory inquiries. • Training and support of employees in GMP-relevant questions as well as promotion of quality awareness within production. • Active cooperation with production, Quality Assurance, and other interface partners to develop pragmatic and GMP-compliant solutions. • Participation in the QA on-call service after appropriate training as well as support for quality-critical questions outside of regular working hours. Qualifications and professional experience • Completed Master's degree in pharmacy, chemistry, biology, biotechnology, engineering, or a comparable natural science discipline. • At least 3 years of experience in a GMP-regulated environment, ideally in the pharmaceutical industry and/or in the field of aseptic manufacturing or filling. • Experience in dealing with deviations, changes, risk analyses, and GMP documentation. • Good knowledge of GMP requirements; experience with Annex 1, isolator technology, or aseptic manufacturing processes is an advantage. • Analytical mindset as well as the ability to grasp complex issues in a structured manner, prioritize them, and communicate them understandably. • High resilience, flexibility, and decision-making ability even in demanding situations with competing priorities. • Strong communication and stakeholder management skills as well as a good sense in dealing with different stakeholder groups. • Fluent German as well as very good English skills in spoken and written form. • Willingness to participate in the QA on-call service as well as to work outside of regular working hours. About this position • The work area includes both office activities (approx. 60 % of working time) as well as inspections in cleanrooms of class C/D/E. • The inspections are tied to production times (office hours, but also assignments early in the morning, late in the evening, and at night are possible). Do you see yourself in this position? Then we would be happy to receive your CV and your work references as an application. CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.