Senior QA Expert Audit Management

Take ownership of complex inspections and customer audits by coordinating preparation, managing stakeholders, hosting auditors, and driving successful outcomes across two sites in Switzerland. Lead and coordinate Health Authority inspections and customer audits across the Stein manufacturing site and Basel QC laboratory, ensuring successful execution from planning through post-audit follow-up. Act as the primary front-office representative during inspections and audits, hosting inspectors and auditors, facilitating discussions, and ensuring a professional and seamless audit experience. Drive inspection and audit readiness activities by partnering with SMEs and cross-functional teams to prepare documentation, manage stakeholder communication, and support CAPA responses. Oversee audit-related activities in TrackWise, including follow-up actions, compliance monitoring, and ensuring timely closure of commitments and corrective actions. Contribute to the continuous improvement of the Quality Management System by supporting GMP compliance initiatives, self-inspections, change controls, non-conformities, document management, and strategic growth projects.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees.

• Proven experience managing Health Authority inspections, including Swissmedic inspections, is essential; exposure to FDA inspections is a strong advantage.

• Fluent communication skills in both German and English are required, with the ability to confidently engage with inspectors, auditors, customers, and internal stakeholders.

• Degree in a life sciences discipline such as Pharmacy, Chemistry, Biology, Biotechnology, or a related field.

• Strong working knowledge of GMP requirements within the pharmaceutical industry and experience driving inspection and audit readiness activities.

• Experience in sterile manufacturing environments and/or with biologics manufacturing is highly desirable.