GxP Compliance Expert (m/f/d) – Clinical Distribution

About the role

F. Hoffmann-La Roche's Clinical Distribution organisation (Deliver) is looking for a GxP Compliance Expert in Kaiseraugst. The role sits in the Network & Capabilities chapter of the Clinical Distribution Team and drives GxP compliance and quality for the global Roche/Genentech portfolio of more than 500 studies. The work week is standard, 40 hours, with three days on site and two days home office.

Key responsibilities

• SME for all GxP and compliance topics, including proactive advice and system administration of quality documents (Veeva)
• Audit and inspection SME for Deliver, covering non-study-specific examinations
• Process deviations, CAPAs, changes and process improvements, and own quality KPIs for Deliver
• Manage the structure of departmental SOPs and other regulated documents
• Report quality and compliance trends and implement GxP training and employee development
• Conduct root cause analysis to address quality, regulatory and compliance issues

Required profile

• Degree (BA, MS, MBA) in a relevant field such as supply chain, pharmacy, biology, chemistry or industrial engineering
• At least 6 years of professional experience in GxP compliance and the clinical supply chain
• Knowledge of cGMP standards and experience with internal (PTQ, Pharma-Technical Quality) and external (FDA, EMA) regulatory inspections
• Deep understanding of warehouse, transportation and clinical supply chain distribution
• Fluent written and spoken German and English

Required skills

• Google applications and MS Office (Word, Excel, PowerPoint)
• Visio
• Veeva and Cornerstone

Applications (CV, certificates and training certificates) are sent by e-mail to the staffing agency We Make It.