GxP Compliance Expert – Clinical Supply Chain

About the role

A leading pharmaceutical company, represented by its recruiter, is looking for a GxP Compliance Expert for its clinical supply chain function. The role is based in Kaiseraugst, at 100% workload, with up to two days per week of home office. It is a temporary contract of 12 months via Randstad, starting as soon as possible and with a possible extension.

Key responsibilities

• Serve as subject matter expert for all GxP and compliance topics, including system administration of Veeva quality documents
• Act as SME for audits and inspections related to non-study-specific examinations
• Process deviations, CAPAs, changes and process improvements, and own the quality KPIs for Deliver
• Drive improvement of deviation management and run root cause analyses for quality, regulatory and compliance issues
• Manage the structure of departmental SOPs and other regulated documents
• Own trend reporting across Quality and Compliance requirements
• Implement GxP training and develop employees' GxP knowledge

Required profile

• University degree (BA, MS, MBA) in a relevant field such as supply chain management, pharmacy, biology, chemistry or industrial engineering
• At least 6 years of professional experience
• Fluent written and spoken German and English
• Customer-oriented, structured work style and strong communication skills

Required skills

• Extensive knowledge of cGMP standards and hands-on experience with internal (PTQ, Pharma-Technical Quality) and external (FDA, EMA) regulatory inspections
• End-to-end supply chain knowledge, including warehouse and transportation management, logistics and clinical supply chain distribution
• Proficiency in Google applications, MS Office (Word, Excel, PowerPoint), Visio, Veeva and Cornerstone