QA Expert Audits and Inspections 80-100%

Lonza Group; Stein; Hybrid; EUR 131,000 - 197,000; Full time

Benefits offered by this job

Global benefits

Local benefits

Job summary

Lonza Group Ltd. is seeking an Audit & Inspection Coordinator to support regulatory inspections and customer audits at our Stein site in Switzerland. You will manage preparation, hosting, inspection logistics, and documentation while collaborating with global stakeholders to ensure compliance and timely responses.

The role emphasizes back‑office excellence, CAPA tracking in TrackWise, and continuous improvement of inspection readiness for a state‑of‑the‑art facility. Travel to Basel approx.

Qualifications

• Bachelor's or Master's degree in Life Sciences or related field with GMP experience.
• Experience coordinating regulatory inspections and customer audits.
• Solid understanding of GMP principles and quality processes.

Responsibilities

• Coordinate regulatory inspections and customer audits, including preparation and hosting activities.
• Serve as back‑office partner for audits, ensuring timely responses and clear communication.
• Lead follow‑up activities in TrackWise and support CAPA development.

Skills

Audit coordination

Quality systems

GMP knowledge

English fluency

Travel willingness

Regulatory inspections

Education

Bachelor's or Master's in Life Sciences

Tools

TrackWise

Job description

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Every day, our teams across the world work together to turn scientific breakthroughs into life‑changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong.

You will coordinate and support audits and inspections at an innovative manufacturing site equipped with state‑of‑the‑art sterile filling technologies, ensuring the smooth execution of all audit‑related activities from the back office. This role offers exciting exposure to international customer and regulatory inspections, along with excellent opportunities to further develop your expertise in quality, compliance, and inspection management over the long term. 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 dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.
• The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits
• Our local benefits can be found here: 3cf206339e0e4e41a77e8c806138c2b5

What you will do:

• 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 and inspections, ensuring efficient coordination, timely responses, and seamless communication with internal and external stakeholders.
• Drive audit and inspection follow‑up activities in TrackWise, partnering with subject matter experts to develop and track effective CAPA plans.
• Contribute to inspection readiness initiatives for a state‑of‑the‑air sterile filling facility, helping maintain a culture of continuous compliance and quality excellence.
• Support GMP compliance and Quality Management System activities, including change controls, deviations, CAPAs, self‑inspections, document management, and implementation of global quality standards.

What we are looking for:

• Bachelor's or Master's degree in Life Sciences or a related field, combined with several years of work experience in a GMP‑regulated manufacturing environment (e.g. in shopfloor GMP production, MSAT, QC or similar background).
• Fluent English communication skills are essential, enabling effective collaboration with global stakeholders, customers, and regulatory authorities.
• Strong understanding of GMP principles, quality processes, and compliance requirements is a must; experience in sterile manufacturing or biologics/drug substance operations is an advantage.
• Customer audit and/or regulatory inspection experience is beneficial, with a keen interest in developing expertise in audit and inspection management.
• Willingness to work primarily at our Stein site and travel approximately one day per week to Basel; German skills are a plus, and you should be motivated to further develop your German language proficiency to support your own long‑term career growth.

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast‑moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow.

Every day, our teams across the world work together to turn scientific breakthroughs into life‑changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong. We are the makers of the medicines of tomorrow.