At Roche you can show up as yourself, embraced for the unique qualities you bring. The Position Roche is advancing science and building a new portfolio of products in Cell and Gene Therapy (CGT), driving life‑changing treatments for patients. We are currently searching for a Computer System Validation Lead to oversee the compliance and validation of our digital solutions. In this position, your primary focus will be ensuring that all software, systems and processes function exactly as intended and strictly align with regulatory requirements and quality standards. By actively collaborating with product managers, RTEs, software developers, system owners and key business stakeholders, you will empower teams to successfully manufacture and deliver high‑quality pharmaceutical products. Formulate and deploy validation strategies for digital solutions, aligning with corporate benchmarks, industry best practices and regulatory mandates. Produce exhaustive validation protocols and plans for CGT applications, automated tools and data‑driven interfaces, ensuring comprehensive documentation of all activities Ensure strict adherence to data integrity regulations and GMP standards, maintaining highly accurate logs, plans and change controls Qualification & Core Testing: Work alongside multidisciplinary teams and QA Subject Matter Experts (SMEs) to perform qualification benchmarks, execute test scenarios,



analyse performance data and report findings Assume the role of System Owner for assigned software applications throughout the CGT digital landscape Bachelor's degree in computer science, information systems or a related study (or equivalent project‑related experience) ~5+ years of relevant experience as a Validation / CSV Expert providing mission‑critical services in a global organisation, preferably within the highly regulated Life Sciences industry ~ Practical experience with cloud platforms (AWS, Google Cloud) and ServiceNow, alongside familiarity with test automation processes. ~ Professional mastery of IT Service Management frameworks, specifically ITIL V3/V4. ~ Prior knowledge of cell & gene therapy or pharmaceutical supply chain processes is highly preferred. Able to articulate complex ideas clearly and proactively direct validation initiatives across global, cross‑functional teams Completely fluent in English (written and verbal) with a strong customer‑service orientation 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 general impact.

📌 Computer System Validation Lead For Cell (España)
🏢 Roche
📍 España