Manager Deviation & QMS Deployment (70%)

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 produce life-saving therapies for people with serious and rare diseases worldwide. For our QA Compliance Team, we are looking for a committed personality as Manager Deviation & QMS Deployment (70%) - (m/f/d) (fixed-term until 31.05.2027) In this fixed-term role, you will take on technical responsibility for local deviation management and actively contribute to the continuous further development of our Quality Management System (QMS). Together with local and global stakeholders, you will ensure that quality processes are harmonized, regulatory requirements are met, and sustainable improvements are implemented. Competencies and responsibilities • You will assume technical responsibility for the local Deviation Management System and act as Local Process Champion for the Bern site. • You will continuously develop processes, SOPs, and work instructions in the area of deviation management and ensure their regulatory compliance. • You will support change and complaint management as well as other global QMS processes in close cooperation with local and global quality functions. • You will coordinate and accompany complex deviations, support root-cause analyses, and promote the application of suitable investigation methods. • You will lead or support improvement projects for the harmonization and optimization of quality processes and quality standards. • You will prepare audits and regulatory inspections, present your areas of responsibility to internal and external auditors, and support the processing of audit observations. • You will create KPI and trending evaluations, derive improvement measures, and present relevant quality metrics to stakeholders. • You will conduct training and requalifications within your area of responsibility and support employees in the application of QMS processes. Qualifications and professional experience • Completed Bachelor's or Master's degree in pharmacy, chemistry, biology, or a comparable natural science discipline. • Several years of professional experience in a GMP-regulated environment, ideally in the area of Quality Assurance, Compliance, or Quality Management Systems. • Experience in deviation management as well as a good understanding of investigations and root-cause analyses are an advantage. • Experience in the creation and maintenance of SOPs as well as in conducting training and requalifications. • Analytical, structured, and solution-oriented way of working as well as the ability to communicate complex matters clearly. • Strong communication and stakeholder management skills as well as enjoyment of cross-departmental collaboration. • Very good German and English skills, both written and spoken. Do you see yourself in this position? Then we would be pleased to receive your CV, your work certificates, and your diplomas as part of your 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.