QA Sterility Assurance Manager 80-100%

The QA Sterility Assurance Manager at Lonza is responsible for ensuring the sterility and quality of products, focusing on contamination control and regulatory compliance. Lonza is a global company dedicated to manufacturing medicines and life science products, with a strong emphasis on innovation and quality. The QA Sterility Assurance Manager will lead the site's sterility assurance strategy, ensuring compliance with EU GMP Annex 1 and other global regulations. This involves overseeing contamination control, environmental monitoring, cleaning, disinfection, and aseptic manufacturing activities. The role also includes supporting facility design, qualification, validation, and technology transfers, as well as implementing new product introductions and innovative technologies. The manager will champion a culture of quality and continuous improvement, leading risk assessments, trend analysis, and training programs. Additionally, they will represent Quality Assurance during inspections, audits, and regulatory interactions, ensuring the site is always ready for inspections and fostering collaboration across different teams. To qualify for this role, candidates must have proven expertise in sterility assurance, with a deep understanding of EU GMP Annex 1 and hands-on experience in implementing and maintaining these requirements in a sterile manufacturing environment. Strong knowledge of Contamination Control Strategy (CCS) and extensive experience in aseptic processing, including media fills, contamination risk management, and sterile manufacturing operations, are essential. Candidates should also have a proactive and solution-oriented mindset, with a passion for identifying root causes and implementing sustainable corrective actions. Excellent communication and influencing skills, along with fluency in English, are required. German language skills and audit experience are considered strong advantages. Nice-to-have skills include experience in a rapidly expanding site and the ability to work remotely for up to 20% of the time, with requests considered on a case-by-case basis. The role is based in Stein, AG, Switzerland, with relocation assistance available for eligible candidates and their families. Lonza offers an agile career, a dynamic work culture, and an inclusive and ethical workplace, along with competitive compensation and numerous lifestyle, family, and leisure benefits. What the role asks for: - Proven expertise in sterility assurance, with a deep understanding of EU GMP Annex 1 and hands-on experience implementing and maintaining Annex 1 requirements in a sterile manufacturing environment. - Strong knowledge of Contamination Control Strategy (CCS). - Extensive experience in aseptic processing, including media fills, contamination risk management, and sterile manufacturing operations. - Fluency in English. - Proactive and solution-oriented mindset, with a passion for identifying root causes and implementing sustainable corrective actions. - Nice-to-have: German language skills and audit experience.