Overview
In this role, you will own Health Authority inspections and customer audits across two Swiss sites, coordinating planning, execution, and post-audit follow-up. You will host inspectors, guide discussions, and ensure a smooth, professional audit experience. You’ll drive audit readiness with cross-functional teams, manage documentation and CAPA responses, and support ongoing GMP/QMS improvements in a dynamic growth environment.
Leistungen / Benefits
- remote work up to 20%
- lifestyle benefits
- family benefits
- competitive salary
- inclusive workplace
- ethical culture
Verantwortungsbereiche
- Lead and coordinate Health Authority inspections and customer audits at Stein site and Basel QC lab from planning to post-audit follow-up
- Act as primary front-office representative during inspections, hosting inspectors and facilitating discussions
- Drive audit readiness by partnering with SMEs and cross-functional teams to prepare documentation, manage stakeholder communication, and support CAPA responses
- Oversee audit-related activities in TrackWise, including follow-up actions, compliance monitoring, and timely closure of commitments and corrective actions
- Contribute to continuous improvement of the Quality Management System by supporting GMP compliance initiatives, self-inspections, change controls, non-conformities, document management, and strategic growth projects
Zentrale Anforderungen
- Proven experience managing Health Authority inspections, including Swissmedic; FDA exposure is an advantage
- Fluent German and English communication skills
- Degree in a life sciences discipline such as Pharmacy, Chemistry, Biology, Biotechnology, or related field
- Strong knowledge of GMP requirements in pharmaceutical industry and experience driving inspection readiness
- Experience in sterile manufacturing environments and/or biologics manufacturing is highly desirable
- Diplomatic communication
- Stakeholder management
- Cross-functional collaboration
- TrackWise
- GMP compliance
- CAPA management
Senior QA Expert Audit Management 80-100% in Basel Arbeitgeber: Lonza
Lonza ist ein hervorragender Arbeitgeber, der eine dynamische Arbeitskultur und flexible Arbeitsmöglichkeiten bietet, um die besten Talente zu fördern. Mit einem starken Fokus auf persönliche Entwicklung und Teamarbeit ermöglicht Lonza seinen Mitarbeitern, ihre Karriere in einem bedeutenden Bereich wie der internen Revision voranzutreiben, während sie gleichzeitig zur Verbesserung von Millionen von Leben beitragen. Die enge Zusammenarbeit vor Ort fördert nicht nur den Austausch von Ideen, sondern auch die technische Präzision, die für die Herstellung von Arzneimitteln erforderlich ist.
