GxP Compliance Expert – Clinical Distribution & Audits

We make it GmbH; Kaiseraugst; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche is seeking a GxP Compliance Expert to join the Clinical Distribution team, driving GxP compliance and quality for the global Roche/Genentech study portfolio. You will manage deviations, CAPAs, and inspections, providing expert support across Deliver.

The ideal candidate has a university degree and extensive GxP experience, with strong regulatory knowledge, audit skills, and fluency in German and English. Experience with Veeva, Cornerstone, and QA tools is preferred.

Qualifikationen

• You hold a university degree in a relevant field with several years of solid experience in GxP compliance and the clinical supply chain.
• Proven expertise in regulatory requirements and quality standards, plus experience with audit/inspection processes.
• Strong communication and organisational skills with fluency in German and English.

Aufgaben

• Provide proactive GxP guidance and manage deviations/CAPAs/improvements.
• Act as the audit/inspection SME for Deliver across non-study specific examinations.
• Oversee regulated documents, and drive quality KPI ownership and training initiatives.
• Coordinate SOPs and other regulated documents across the department.
• Lead trend reporting for Quality and Compliance requirements.

Kenntnisse

GxP compliance

Regulatory inspections

Quality management

Audit experience

German language

English language

Ausbildung

University degree in a relevant field (BA/MS/MBA)

Tools

Veeva

Cornerstone

MS Office

Visio

Jobbeschreibung

Roche is seeking a GxP Compliance Expert to join the Clinical Distribution team, driving GxP compliance and quality for the global Roche/Genentech study portfolio. You will manage deviations, CAPAs, and inspections, providing expert support across Deliver.

The ideal candidate has a university degree and extensive GxP experience, with strong regulatory knowledge, audit skills, and fluency in German and English. Experience with Veeva, Cornerstone, and QA tools is preferred.