Senior QA Expert Audit Management 80-100%

Lonza; Stein; Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Stein (AG), Switzerland, leads Health Authority inspections across its Stein site and Basel QC laboratory, coordinating preparation, hosting inspectors, and driving successful audit outcomes.

You will collaborate with SMEs and cross-functional teams to ensure GMP readiness, CAPA handling, and robust audit processes, with on-site work and up to 20% remote flexibility.

Qualifikationen

• Proven experience managing Health Authority inspections (Swissmedic).
• Fluent in German and English for interactions with inspectors and stakeholders.
• Degree in life sciences; strong GMP knowledge and regulatory understanding.

Aufgaben

• Lead and coordinate Health Authority inspections across Stein site and Basel QC laboratory.
• Host inspectors, manage discussions, and ensure a smooth audit experience.
• Drive inspection readiness with SMEs; prepare documentation and CAPA responses; track actions in TrackWise.

Kenntnisse

German

English

Ausbildung

Life sciences degree

Tools

TrackWise

Jobbeschreibung

Switzerland, Basel

Switzerland, Stein

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Take ownership of complex inspections and customer audits by coordinating preparation, managing stakeholders, hosting auditors, and driving successful outcomes across two sites in Switzerland. Working closely with SMEs, customers, and leadership teams, you will combine technical understanding, diplomatic communication, and strategic problem-solving to maintain continuous audit readiness and contribute to one of the industry's most dynamic growth environments. Check out Your Career in Drug Product Services at Lonza !

This role is primarily based on site. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case‑by‑case basis, in line with business needs.

What You Will Get

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

Our local benefits: 3cf206339e0e4e41a77e8c806138c2b5

What You Will Do

• 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.

What We Are Looking For

• 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.

About Lonza

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. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R78684