GxP Compliance Expert / GxP Compliance Expertess

GxP Compliance Expert

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, housing important research and development functions. We are currently seeking a Research Associate in vivo (m/f/d) for our long-term client, F. Hoffmann-La Roche AG, located in Kaiseraugst.

Background

At Roche, we are driven by the aspiration for a healthier future. Our commitment to innovation is unwavering as we advance science to ensure that everyone has access to the healthcare they need today and for generations to come. We aim to create a world where we all have more time with our loved ones.

The Clinical Distribution organization is dedicated to ensuring that the right product is available at the right place and time, thereby preventing treatment delays for patients and ensuring the timely execution of clinical trials.

The GxP Compliance Expert will be a vital member of the Network & Capabilities Chapter within the Clinical Distribution Team (Deliver), which shares accountability for all elements of clinical supply chain distribution across the global Roche/Genentech portfolio of over 500 studies. This role focuses on driving GxP compliance and maintaining quality within Clinical Distribution (Deliver).

Tasks & Responsibilities

• Serve as the Subject Matter Expert (SME) for all GxP and compliance-related topics, providing proactive advice and system administration for Veeva quality documents.
• Act as the Audit/Inspection SME for Deliver during non-study specific examinations.
• Process deviations, CAPAs, and changes, while managing improvement processes.
• Own quality KPIs for Deliver and manage deviation management improvement processes.
• Provide comprehensive compliance expertise to the business, conducting Root Cause Analysis (RCA) to address quality, regulatory, and compliance-related issues.
• Manage the structure of the department's SOPs and regulated documents, collaborating with the chapter's SMEs for business expertise.
• Oversee trend reporting across quality and compliance requirements.
• Implement GxP training and further develop employees' GxP knowledge.

Must Haves

• A degree (BA, MS, MBA) in a relevant field (e.g. Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering and Management) with significant expertise and years of senior professional experience.
• Minimum of 6 years of professional experience.
• Extensive knowledge of cGMP standards and hands-on experience with internal (PTQ, Pharma-Technical Quality) and external (e.g., FDA, EMA) regulatory inspections.
• A deep understanding of end-to-end supply chain management, including warehouse and transportation management, logistics, and clinical supply chain distribution processes.
• Strong interpersonal, communication, organizational, and prioritization 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 be offered

• An opportunity to work in one of the world's most important pharmaceutical companies.
• A modern campus with abundant green spaces and collaborative meeting areas.
• A central location in Basel.
• A varied job profile with opportunities for further training through temptraining.
• The chance to work within a dynamic and motivated team.

If you are interested, please apply online using the form below. Only applications matching the job profile will be considered.