GLP System Owner & Analyst

This role is for a GLP System Owner and Analyst within the pRED Computer System GxP Organization in Basel. The primary responsibilities include the implementation, operation, maintenance and support of GLP systems for the pRED Pharmaceutical Sciences GLP Test Facility.

The System Owner will ensure that the systems adhere to Swiss-based Good Laboratory Practices (GLP) and meet regulatory requirements. Additionally, as a System Analyst, the role involves managing and supporting computer system validation projects to meet the business' data processing needs while maintaining regulatory compliance., * System Lifecycle Management: You will be responsible for the full lifecycle of GLP systems, including implementation, operation, maintenance, and support, in compliance with regulatory and internal policies.

• Project & Validation Management: You will lead and support GLP computerised system validation projects, from defining user requirements and data workflows to coordinating development and testing activities.
• Strategic Planning: This role includes both short and long-range planning for GLP digital services and contributing to key system maintenance concepts like backup, security, and disaster recovery.
• Resource Coordination: You will manage and coordinate both internal teams and external vendors to ensure successful project implementation and ongoing system operations.
• Compliance & Audits: You will maintain a deep understanding of GLP regulations and support internal and external audits.

Do you have experience in Scrum?, * 5+ years of experience leading and managing GxP systems throughout their entire lifecycle.

• Proven expertise in Computer System Validation (CSV) and device qualification, specifically with FDA 21 CFR Part 11 and GLP (i.e. OECD Principles of Good Laboratory Practice).
• Proficient in Agile Scrum and other methodologies, with strong skills in tools like JIRA and ServiceNow.
• A flexible, pragmatic, and solution-oriented mindset, able to manage multiple parallel tasks and work collaboratively with diverse teams.
• Excellent communication skills in English, adept at leading effective meetings and workshops.
• Awareness, understanding and possible experience with emerging technologies such as DevOps and AI.

#ComputationCoE

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.   You must create an Indeed account before continuing to the company website to apply