QA & Regulatory Inspection Specialist (Sterile Manufacturing)

Lonza Group Ltd.; Stein (AR); Hybrid; CHF 110,000 - 140,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Global benefits

Remote flexibility

Job summary

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.

Responsibilities

• 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.

Skills

Fluent English

GMP principles knowledge

Audit/inspection experience

TrackWise familiarity

Travel willingness

Education

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

Job description

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