GxP Compliance Expert — Clinical Supply Chain Leader

ITech Consult AG; Kaiseraugst; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche in Kaiseraugst seeks a GxP Compliance Expert to join the Clinical Distribution Team. You will drive GxP compliance across the Deliver chapter, provide proactive regulatory advice, manage deviations and CAPAs, and support inspections with SME guidance.

The role requires a university degree and extensive GxP and clinical supply chain experience, fluency in German and English, and hands-on familiarity with regulatory audits, quality systems such as Veeva, and KPI ownership.

Qualifikationen

• University degree in a relevant field with extensive experience in GxP compliance and the clinical supply chain.

Aufgaben

• SME for all GxP and compliance topics, incl system administration (Veeva quality docs)
• Audit/Inspection SME for Deliver for non-study examinations
• Process deviations, CAPAs, changes, and process improvements
• Quality KPI ownership for Deliver
• Deviation management improvement processes
• Root Cause Analysis (RCA) to address quality/regulatory issues
• Maintaining SOPs and other regulated documents
• Trend reporting across Quality and Compliance
• Implementing GxP training and developing employees' GxP knowledge

Kenntnisse

GxP compliance

German language

English language

Regulatory inspections

Quality management

Ausbildung

BA/MS/MBA in relevant field

Tools

Veeva

Cornerstone

MS Office

Visio

Google applications

Jobbeschreibung

Roche in Kaiseraugst seeks a GxP Compliance Expert to join the Clinical Distribution Team. You will drive GxP compliance across the Deliver chapter, provide proactive regulatory advice, manage deviations and CAPAs, and support inspections with SME guidance.

The role requires a university degree and extensive GxP and clinical supply chain experience, fluency in German and English, and hands-on familiarity with regulatory audits, quality systems such as Veeva, and KPI ownership.