Computer System Validation Lead - Cell & Gene Therapy

About the role

Roche is building a new portfolio of Cell and Gene Therapy (CGT) products and is looking for a Computer System Validation Lead to oversee the compliance and validation of its digital solutions. The role ensures that software, systems and processes work as intended and meet regulatory requirements and quality standards, working with product managers, RTEs, software developers, system owners and business stakeholders.

Key responsibilities

• Formulate and deploy validation strategies for digital solutions aligned with corporate benchmarks, industry best practice and regulatory mandates
• Produce validation protocols and plans for CGT applications, automated tools and data-driven interfaces
• Conduct risk assessments in the GMP environment and ensure adherence to data integrity regulations and GMP standards
• Work with QA SMEs to run qualification benchmarks, test scenarios and performance analysis
• Advocate for improved validation methodologies, tooling and systems
• Act as System Owner for assigned software applications

Required profile

• Bachelor's degree in computer science, information systems or a related field (or equivalent project experience)
• 5+ years of experience as a Validation / CSV expert in a global organization, preferably in Life Sciences
• Strong leadership, problem-solving and stakeholder management skills, with fluency in English
• Prior knowledge of cell & gene therapy or pharmaceutical supply chain processes is highly preferred

Required skills

• Advanced expertise in Computer Systems Validation (CSV) in a regulated GMP environment
• Knowledge of FDA CFR Part 11, HIPAA, GDPR and GxP documentation
• Experience with cloud platforms (AWS, Google Cloud) and ServiceNow
• Familiarity with test automation and ITIL V3/V4