GxP Compliance Expert

The role of GxP Compliance Expert is within Roche Switzerland, a company that bridges pharmaceuticals and diagnostics. The company is known for its significant research and development functions. The GxP Compliance Expert is part of the Clinical Distribution Team, specifically within the Network & Capabilities Chapter. This role focuses on ensuring GxP compliance and quality within the clinical supply chain distribution for Roche's global portfolio of over 500 studies. The main day-to-day responsibilities include providing proactive GxP advice, managing deviations, CAPAs, and process improvements. The role also involves acting as a Subject Matter Expert (SME) for audits and inspections, handling regulated documents, analyzing quality trends, and developing the team's GxP training. Additionally, the expert is responsible for quality KPI ownership, deviation management improvement processes, and conducting Root Cause Analysis (RCA) to address quality and compliance issues. To qualify for this role, candidates must have a degree in a relevant field such as Supply Chain Management, Pharmacy, Biology, Chemistry, or Industrial Engineering and Management. At least six years of professional experience is required, along with extensive knowledge of cGMP standards and experience with internal and external regulatory inspections. Proficiency in end-to-end supply chain management, including warehouse and transportation management, logistics, and clinical supply chain distribution processes, is essential. Strong interpersonal, communication, organizational, and prioritization skills are also necessary, with a focus on customer needs. Fluency in both written and spoken German and English is a must. Nice-to-have skills include proficiency in using Google applications, MS Office (Word, Excel, PowerPoint), Visio, and key industry systems such as Veeva and Cornerstone. The role is based in Basel, offering a modern campus with green spaces and meeting areas, a central location, a varied job profile, and further training opportunities through temptraining. The team is described as dynamic and motivated. What the role asks for: - A degree (BA, MS, MBA) in a relevant field (e.g. Supply Chain Management and Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering and Management) - At least 6 years of professional experience - Extensive knowledge of cGMP standards and practical experience with internal (PTQ, Pharma-Technical Quality) and external (e.g. FDA, EMA) regulatory inspections - Deep knowledge in End-to-End-Supply-Chain-Management, including warehouse and transport management, logistics and clinical supply chain distribution processes - Excellent interpersonal, communication, organizational, and prioritization skills with a strong focus on customer needs - Fluently in German and English, spoken and written - Knowledge in the use of Google applications, MS Office (Word, Excel, PowerPoint), Visio and important industry systems like Veeva and Cornerstone