Senior Manager – External Supply Quality Assurance

CSL is a global leader in biotechnology, dedicated to creating and delivering innovative medicines for patients with serious and rare diseases. The company is seeking a seasoned Quality professional to join their External and Supply Quality organization as a Senior Manager, External Supply Quality Assurance. This role involves overseeing the quality of Contract Manufacturing Organizations (CMOs) and leading a small international team based in Bern and Marburg. The Senior Manager will handle the day-to-day responsibilities of managing a team of Quality professionals, ensuring robust quality systems and reliable product supply. This includes leading complex quality topics, monitoring CMO performance, and building strong relationships with external partners. The role also involves representing CSL Quality in various business reviews, cross-functional initiatives, and regulatory activities, as well as supporting the development of the external manufacturing network. To excel in this role, candidates must have a university degree in a relevant scientific, technical, or business discipline, or an equivalent combination of education and experience. A minimum of eight years of experience in a GxP-regulated environment within the pharmaceutical industry is required, along with strong hands-on GMP manufacturing experience in a sterile/aseptic production environment. In-depth knowledge of EU GMP Annex 1 requirements and a strong understanding of relevant pharmaceutical regulations and Quality requirements are essential. Fluency in English is a must, with German language skills being highly desirable. Nice-to-have skills include experience working with CMOs and external manufacturing partners, as well as a proven track record in people management and leadership. The ability to manage complex quality issues, make sound risk-based decisions, and drive sustainable resolutions is also valuable. The role offers the opportunity to work in a dynamic, global matrix organization, with a focus on continuous improvement and standardization. The position is based in Bern and Marburg, offering a collaborative and innovative work environment. The team is dedicated to driving alignment and influencing stakeholders in a complex global matrix environment, ensuring business continuity and contributing to the broader External and Supply Quality strategy. What the role asks for: - University degree in a relevant scientific, technical or business discipline, or an equivalent combination of education and relevant professional experience. - Minimum of 8 years of experience in a GxP-regulated environment within the pharmaceutical industry. - Strong hands-on GMP manufacturing experience in a sterile/aseptic production environment. - In-depth knowledge and practical understanding of EU GMP Annex 1 requirements and their application within sterile pharmaceutical manufacturing. - Strong understanding of relevant pharmaceutical regulations and Quality requirements, including European and international regulatory expectations. - Fluency in English, both written and spoken. - German language skills are highly desirable.