Experteer Overview In this role you define and implement risk-based CSV and QA strategies for global networks, ensuring GMP-compliant computerized systems across the enterprise. You act as the primary quality SME for deviations, CAPAs, and investigations, partnering with cross-functional teams to resolve complex compliance issues. You will approve system releases and lead periodic system reviews, while fostering a Speak Up culture and driving continuous improvement through CSA-based validation approaches. This position sits at the intersection of quality, technology, and global operations, contributing to Roche’s mission to advance healthcare.Compensaciones / Beneficios
- Define and implement risk-based CSV and QA strategies across global networks
- Oversee GMP compliance and inspection readiness for computerized systems supporting integral operations
- Serve as the Primary Quality Subject Matter Expert and POC for deviations, CAPAs, and investigations
- Collaborate as a Quality representative on cross-functional,



multi-site teams to resolve compliance challenges
- Approve system releases according to CSV standards and lead periodic reviews of global computer systems
- Champion a Speak Up culture and foster open communication across sites
- Identify and lead continuous improvement initiatives by applying CSA trends and validation frameworksResponsabilidades
- degree in Physical Sciences, Computer Science, or a related field (with 5+ years in QA/QC/ERP in pharma)
- 5+ years in GxP regulations, CSV, and Data Integrity principles
- proven track record supporting QC/QA/ERP implementations (e.G., SAP) across the system lifecycle
- experience with systems management and testing tools (ALM, Gitlab, Jira, ServiceNow, SAP Solution Manager)
- agile collaborator and clear communicator with experience coaching cross-functional stakeholdersRequisitos principales
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📌 Computer Systems Compliance Lead (Madrid)
🏢 Roche
📍 Madrid