Experteer Overview 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, 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 •

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