GMP Audit & Inspection Coordinator (Onsite/Hybrid)

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

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.