Senior QA Expert: Health Authority & Audit Lead (Hybrid)

Lonza; Basel; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career growth

Inclusive workplace

Performance-based compensation

Zusammenfassung

Lonza is seeking a skilled Inspector/Auditor to coordinate Health Authority inspections and customer audits at the Stein manufacturing site and Basel QC laboratory in Switzerland. You will ensure readiness, manage stakeholders, and host auditors to deliver a smooth, compliant audit experience.

The role requires Swissmedic inspection experience, strong GMP knowledge, and fluent German and English. Join Lonza to contribute to a high-precision, quality-driven environment with ongoing regulatory

Qualifikationen

• Proven experience managing Health Authority inspections, including Swissmedic inspections, is essential.
• Degree in life sciences (pharmacy, chemistry, biology, biotech or related field) required.
• Strong working knowledge of GMP requirements in pharma and inspec­tion readiness.
• Experience in sterile manufacturing or biologics manufacturing is a plus.

Aufgaben

• Lead and coordinate Health Authority inspections and customer audits across Stein site and Basel QC lab; manage planning and post-audit follow-up.
• Act as front-office representative during inspections; host inspectors and ensure professional audit experience.
• Drive inspection readiness by partnering with SMEs and cross-functional teams, preparing documentation and CAPA responses.
• Oversee audit-related activities in TrackWise; monitor follow-up actions and timely closure of commitments.
• Support GMP compliance initiatives and documentation management within the QMS.

Kenntnisse

Health Authority inspections

German & English

GMP knowledge

Audit readiness

Ausbildung

Life sciences degree

Tools

TrackWise

Jobbeschreibung

Lonza is seeking a skilled Inspector/Auditor to coordinate Health Authority inspections and customer audits at the Stein manufacturing site and Basel QC laboratory in Switzerland. You will ensure readiness, manage stakeholders, and host auditors to deliver a smooth, compliant audit experience.

The role requires Swissmedic inspection experience, strong GMP knowledge, and fluent German and English. Join Lonza to contribute to a high-precision, quality-driven environment with ongoing regulatory