Experteer Overview
A continuación se detalla todo lo que necesita saber sobre lo que implica esta oportunidad, así como lo que se espera de los solicitantes.
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 integral networks
• Oversee GMP compliance and inspection readiness for computerized systems supporting global 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 frameworks
Responsabilidades
• degree in Physical Sciences, Computer xghoner 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 stakeholders
Requisitos principales
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📌 Computer Systems Compliance Lead (Madrid)
🏢 Roche
📍 Madrid