Senior QA Auditor & Inspections Lead (Switzerland)

Lonza; Schweiz; Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Stein, AG, Switzerland, is seeking a Senior QA Expert Audit Management to own and coordinate Health Authority inspections and customer audits across our Stein site and Basel QC laboratory.

The role focuses on planning, hosting inspectors, driving audit readiness with SMEs and cross-functional teams, and ensuring timely CAPA responses within a GMP framework. Up to 20% remote work is possible; on-site collaboration is essential for manufacturing quality.

Qualifikationen

• Proven experience managing Health Authority inspections (Swissmedic preferred).
• Fluent German and English communication with inspectors and stakeholders.
• Strong GMP knowledge within pharmaceutical manufacturing.

Aufgaben

• Lead Health Authority inspections and customer audits across Stein site and Basel QC laboratory.
• Coordinate preparation, host auditors, and manage stakeholder communications.
• Drive audit readiness activities and CAPA responses with SMEs and cross-functional teams.
• Oversee audit-related activities in TrackWise and ensure timely closure of actions.

Kenntnisse

GMP knowledge

Health Authority inspections

German language

English language

Stakeholder management

Ausbildung

Life sciences degree

Jobbeschreibung

Lonza in Stein, AG, Switzerland, is seeking a Senior QA Expert Audit Management to own and coordinate Health Authority inspections and customer audits across our Stein site and Basel QC laboratory.

The role focuses on planning, hosting inspectors, driving audit readiness with SMEs and cross-functional teams, and ensuring timely CAPA responses within a GMP framework. Up to 20% remote work is possible; on-site collaboration is essential for manufacturing quality.