QA Expert - Audits and Inspections (80-100%)

About the role

Lonza is hiring a QA expert to coordinate and support audits and inspections at its manufacturing site in Stein, Switzerland, which uses state-of-the-art sterile filling technology. The role is primarily based on site, with flexibility to work remotely for no more than 20% of the time, and offers exposure to international customer and regulatory inspections. Relocation assistance is available for eligible candidates and their families.

Key responsibilities

• Coordinate and support regulatory inspections and customer audits, including preparation, hosting activities, inspection logistics and audit documentation.
• Act as a key back-office partner during audits, ensuring efficient coordination, timely responses and clear communication with internal and external stakeholders.
• Drive audit and inspection follow-up in TrackWise, partnering with subject matter experts to develop and track CAPA plans.
• Contribute to inspection readiness for the sterile filling facility and help maintain a culture of continuous compliance and quality.
• Support GMP compliance and Quality Management System activities, including change controls, deviations, CAPAs, self-inspections, document management and global quality standards.

Required profile

• Bachelor's or Master's degree in Life Sciences or a related field, with several years of experience in a GMP-regulated manufacturing environment (shopfloor GMP production, MSAT, QC or similar).
• Fluent English, essential for collaboration with global stakeholders, customers and regulators.
• Strong understanding of GMP principles, quality processes and compliance requirements; sterile manufacturing or biologics/drug substance experience is an advantage.
• Customer audit and/or regulatory inspection experience is beneficial, and willingness to work mainly at the Stein site with about one day per week in Basel.
• German skills are a plus.

What we offer

• An agile career and dynamic working culture in an inclusive, ethical workplace.
• Compensation programs that recognise high performance.
• A range of benefits depending on role and location.