QA Expert Audits and Inspections 80-100%

Lonza; Stein; On-site; Vertraulich; Full time

Benefits offered by this job

Agile career

Inclusive workplace

Performance-based compensation

Benefits vary by role/location

Job summary

Lonza in Stein, AG, Switzerland seeks a Regulatory Audits Coordinator focused on inspections at our state-of-the-art sterile filling facility. This on-site role offers up to 20% remote work and frequent collaboration with global auditors and customers.

You will manage audit logistics, document control in TrackWise, and drive CAPA follow-ups while upholding GMP and Quality Management standards. Travel to Basel may be required; German skills are a plus.

Qualifications

• Bachelor's or Master's in Life Sciences or related field.
• Several years of GMP-regulated manufacturing experience.
• Fluent English with ability to interact with global stakeholders.
• Basic German language skills are a plus.
• Experience with regulatory inspections and customer audits is preferred.

Responsibilities

• Coordinate and support regulatory inspections and customer audits.
• Prepare, host activities, inspection logistics and inspection documentation.
• Act as back-office partner for efficient coordination and timely responses.
• Drive CAPA follow-up in TrackWise with SMEs to develop and track actions.
• Support GMP compliance and QMS activities at a sterile manufacturing site.

Skills

Audit coordination

English fluency

Regulatory inspections experience

Willingness to travel

German welcome

Education

Bachelor's or Master's in Life Sciences

Tools

TrackWise

GMP systems

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. 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 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-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.

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. Apply now.