QA Expert Audits and Inspections 80-100%

CH12 Lonza AG; Stein (AR); Hybride; CHF 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Agile culture

Inclusive workplace

Global benefits

Remote flexibility

Résumé du poste

Lonza Group Ltd. in Stein, AG, Switzerland is seeking a Regulatory Inspections Coordinator to support audits and inspections at our state-of-the-art sterile filling site.

The role focuses on back-office coordination, preparation, hosting activities, and timely responses with internal and external stakeholders. You will drive CAPA follow-ups in TrackWise, support GMP compliance, change controls and deviations, and help maintain a culture of continuous improvement and quality excellence while

Qualifications

• Bachelor's or Master's degree in Life Sciences or related field with GMP manufacturing experience.
• Fluent English with ability to collaborate with global stakeholders.
• Knowledge of GMP principles; experience in sterile manufacturing or biologics is a plus.

Responsabilités

• 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.

Connaissances

Fluent English

GMP principles knowledge

Audit/inspection experience

TrackWise familiarity

Travel willingness

Formation

Bachelor's or Master's degree in Life Sciences or related field

Description du poste

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.

Check out Your Career in Drug Product Services at Lonza!

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.