Experteer Overview

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In this role you will lead validation strategies and oversee the compliance of digital solutions within Roche's CGT portfolio. You will work with cross-functional teams to ensure software, systems, and processes meet regulatory and quality standards, enabling reliable manufacturing of therapies. You drive risk assessments, documentation, and testing to support GMP-compliant digital infrastructure. This position offers impact by shaping validation practices in a cutting‑edge therapeutic area and collaborating across global teams.

Compensaciones / Incentivos
• Formulate and deploy validation strategies for CGT digital solutions and produce validation plans and protocols
• Conduct risk assessments to mitigate GMP-related threats and ensure data integrity and change controls
• Perform qualification benchmarks, run test scenarios, analyze results, and report findings with QA SMEs
• Champion advancement of validation methodologies, tooling,



and processes while staying current with industry trends
• Serve as System Owner for assigned CGT software applications across the digital landscape

Responsabilidades
• 5+ years of experience as a Validation/CSV expert in a global, highly regulated Life Sciences environment
• Advanced expertise in CSV principles, documentation, and practices within GMP
• Knowledge of regulatory standards: FDA CFR Part 11, HIPAA, xqbhyrx GDPR, and current GxP documentation
• Experience with cloud platforms (AWS, Google Cloud) and ServiceNow; familiarity with test automation
• IT Service Management frameworks, specifically ITIL V3/V4
• Prior knowledge of cell u0026 gene therapy or pharmaceutical supply chain processes is highly preferred
• Bachelor's degree in computer science, information systems or a related field
• equivalent project-related experience

Requisitos principales
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📌 Computer System Validation Lead for Cell & Gene Therapy (Madrid)
🏢 Roche
📍 Madrid