QA Expert Audits and Inspections 80-100%

Lonza Group; Stein (AR); Hybrid; Vertraulich; Full time

Job summary

Lonza is seeking a quality-inspection coordinator to support audits and regulatory inspections at our Stein, AG site in Switzerland. The role involves back-office coordination, preparation, hosting activities, logistics, and documentation to ensure smooth audit execution.

It offers exposure to international inspections and opportunities to grow in quality and regulatory fields. The position is primarily on-site with the flexibility to work remotely up to 20% of time and occasional travel to

Qualifications

• Bachelor's or Master's degree in Life Sciences with GMP experience.
• Fluent English; able to interact with global stakeholders and authorities.
• Experience with audits/inspections and CAPA management is preferred.

Responsibilities

• Coordinate and support regulatory inspections and customer audits.
• Act as back-office partner during audits, ensuring timely responses and coordination.
• Drive follow-up activities in TrackWise and develop CAPA plans with SMEs.
• Contribute to inspection readiness for a sterile filling facility and promote quality excellence.
• Support GMP compliance and QMS activities (change controls, deviations, CAPAs, self-inspections).

Skills

GMP knowledge

Audit coordination

English fluent

Stakeholder collaboration

Education

Bachelor's/Master's in Life Sciences

Tools

TrackWise

Job description

Location and relocation assistance

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

Global impact

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.

Role overview

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. It 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.

Work arrangement

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.

Benefits

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-art 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.

What 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. Join us. Be you.