GMP Compliance Expert(m/w/x)

# GMP Compliance Expert **Kaiseraugst** | **Full time** At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### The Position ### GMP Compliance Expert ### A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. ### The Clinical Distribution organization’s objective is to cost-effectively ensure the right product is in the right place at the right time every time, such that no patient will go without treatment and no clinical trial will be delayed. ### The GMP Compliance Expert is a member of the Network & Capabilities Chapter within the Clinical Distribution Team, which is jointly accountable for all elements of clinical supply chain distribution for the global Roche/Genentech portfolio of >500 studies. This role drives GMP compliance and quality within Clinical Distribution. Key duties include proactive GMP advice, managing deviations/CAPAs/improvements, acting as the audit/inspection SME, handling regulated documents, analyzing quality trends, and developing the team’s GMP training. ### The Opportunity: * ### SME for all GMP and compliance related topics (proactive advice on these matters) incl system administration (Veeva quality docs) * ### Audit/Inspection SME for Deliver for non study specific examinations * ### Processing of deviations as well as CAPAs, Changes, Process Improvements * ### Quality KPI Ownership for Deliver * ### Offer comprehensive compliance expertise to the business, conducting Root Cause Analysis (RCA) to identify and address regulatory and compliance-related issues * ### Managing the structure for the departments SOPs and any other regulated documents (The business know-how is provided by the chapter’s SMEs) * ### Quality Incident Trend reports * ### Implementation of GMP training and further development of employees' GMP knowledge ### Who you are ### We are looking for a senior professional (m/f/d) to join our team with significant expertise and extensive years of professional experience. * ### Extensive Knowledge of cGMP standards and experience related to internal (PTQ) and/or external (e.g. FDA, EMA) inspections * ### Strong 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 * ### Strong focus on customer needs * ### Fluent in both written and spoken German and English * ### Knowledge of how to use Google applications, computer programs MS Word/Excel/PowerPoint, Visio, and systems such as Veeva and Cornerstone * ### You hold a degree (BA, MS, MBA) in a relevant field # Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. **Roche is an Equal Opportunity Employer.**