QA Sterility Assurance Manager (80-100%)

About the role

Lonza is looking for a QA Sterility Assurance Manager in Stein, Switzerland, to safeguard products for patients by driving sterility assurance, contamination control and quality across a rapidly expanding site. The role is primarily based on site, with flexibility to work remotely for no more than 20% of the time, on a case-by-case basis.

Key responsibilities

• Lead the site's sterility assurance strategy, ensuring compliance with EU GMP Annex 1 and other global regulatory requirements.
• Drive and continuously improve the Contamination Control Strategy (CCS), overseeing contamination control, environmental monitoring, cleaning, disinfection and aseptic manufacturing.
• Act as a sterility assurance subject matter expert for facility design, qualification, validation, technology transfers, new product introductions and new technologies.
• Lead risk assessments, trend analysis, training and continuous improvement initiatives.
• Represent Quality Assurance during inspections, audits and regulatory interactions, ensuring inspection readiness.

Required profile

• Proven expertise in sterility assurance, with hands-on experience implementing and maintaining EU GMP Annex 1 in a sterile manufacturing environment.
• Strong knowledge of CCS, including developing, challenging and improving contamination control programs.
• Extensive experience in aseptic processing, media fills (APS), contamination risk management and sterile manufacturing.
• Proactive, solution-oriented, with excellent communication and influencing skills.
• Fluent English and confidence representing the company during audits; German and audit experience are strong advantages.

What we offer

• A competitive salary plus lifestyle, family and leisure benefits.
• An agile career, inclusive workplace and compensation programs for high performance.
• Relocation assistance for eligible candidates and their families.