Computer System Validation Lead for Cell & Gene Therapy

En Roche puedes ser tú mismo y sentirte valorado por tus cualidades únicas. Nuestra cultura fomenta la expresión personal, el diálogo abierto y las conexiones genuinas, donde eres valorado, aceptado y respetado por lo que eres, permitiéndote prosperar tanto de manera personal como profesionalmente. Así es como buscamos prevenir, detener y curar enfermedades y asegurarnos de que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Únete a Roche, donde cada voz importa. La posición 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 business minded technology experts in CGT acting as a pioneer in this new era in medicine. 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. Job Responsibilities - Strategy & Validation Execution: 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. - Risk Management & Regulatory Compliance: Conduct comprehensive risk assessments to mitigate potential threats within the GMP environment. 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, analyze performance data, and report findings. - Process Improvement & Leadership: Champion the advancement of validation methodologies, tooling, and systems while keeping abreast of current industry trends and regulatory adjustments. - Application Ownership: Assume the role of System Owner for assigned software applications throughout the CGT digital landscape. Qualifications Education / Experience - 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 organization, preferably within the highly regulated Life Sciences industry - Advanced expertise in Computer Systems Validation (CSV) principles, documentation, and practices within a regulated GMP environment. - Comprehensive understanding of regulatory standards, including FDA CFR Part 11, HIPAA, GDPR, and current GxP documentation specifications. - 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. Personal attributes - Leadership & Problem Solving: Detail-oriented professional with strong analytical and hands-on troubleshooting capabilities. Able to articulate complex ideas clearly and proactively direct validation initiatives across global, cross-functional teams. - Stakeholder Management: Outstanding communication and relationship-building skills, with a proven ability to moderate discussions, resolve conflicts, facilitate collaborative workshops, and serve as a trusted advisor to diverse groups. - Team Collaboration & Mentorship: Highly energetic and positive mindset focused on coaching, mentoring, and fostering seamless cross-group cooperation. - Completely fluent in English (written and verbal) with a strong customer-service orientation. Quienes somos Alcanzar un futuro más saludable es lo que nos impulsa a innovar. Juntos, más de 100.000 empleados en todo el mundo están dedicados a avanzar en la ciencia, asegurando que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Nuestros esfuerzos resultan en más de 26 millones de personas tratadas con nuestros medicamentos y más de 30 mil millones de pruebas realizadas con nuestros productos de Diagnósticos. Nos damos apoyo mutuamente para explorar nuevas posibilidades, fomentar la creatividad y mantener altas nuestras ambiciones, para poder ofrecer soluciones sanitarias que cambian la vida e impactan a nivel global. Construyamos juntos un futuro más saludable. Roche es una empresa que ofrece igualdad de oportunidades.