GxP Compliance Expert

Driving GxP Compliance and Quality in Clinical Distribution

Join a team dedicated to bridging the gap between pharmaceuticals and diagnostics, where innovation drives a healthier future. As a key member of the Network & Capabilities Chapter within the Clinical Distribution Team, you will be jointly accountable for all elements of clinical supply chain distribution for a global portfolio of over 500 studies. Your primary objective is to cost-effectively ensure the right product is in the right place at the right time, ensuring no patient goes without treatment and no clinical trial is delayed.

Key Responsibilities

• Serve as the Subject Matter Expert (SME) for all GxP and compliance-related topics, providing proactive advice and managing system administration for quality documentation.
• Act as the Audit and Inspection SME for non-study specific examinations within the distribution network.
• Process deviations, CAPAs, changes, and process improvements while owning Quality KPIs for the department.
• Offer comprehensive compliance expertise by conducting Root Cause Analysis (RCA) to identify and address quality, regulatory, and compliance-related issues.
• Manage the structure for departmental SOPs and other regulated documents, utilizing business know-how provided by chapter SMEs.
• Ensure responsibility for trend reporting across Quality and Compliance requirements.
• Implement GxP training programs and further develop employees' GxP knowledge.

Essential Qualifications

• A degree (BA, MS, MBA) in a relevant field such as Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, or Industrial Engineering and Management.
• At least 6 years of professional experience with significant senior-level expertise.
• Extensive knowledge of cGMP standards and hands-on experience navigating internal (PTQ, Pharma-Technical Quality) and external (e.g., FDA, EMA) regulatory inspections.
• Deep understanding of end-to-end supply chain management, specifically encompassing warehouse and transportation management, logistics, and clinical supply chain distribution processes.
• Strong interpersonal, communication, organisational, and prioritisation skills with a steadfast focus on customer needs.
• Fluency in both written and spoken German and English.
• Proficiency in Google applications, MS Office (Word, Excel, PowerPoint), Visio, and key industry systems such as Veeva and Cornerstone.

What You Will Experience

• An opportunity to work in one of the world's most important pharmaceutical companies.
• A modern campus with plenty of green spaces and meeting areas in a central location in Basel.
• A varied job profile within a dynamic and motivated team.
• Further training opportunities to support your professional development.