CGT CSV Lead: Drive GMP‑Aligned Validation & Compliance

Roche; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Roche is seeking a Computer System Validation Lead to oversee compliance and validation of digital solutions in CGT. You will ensure software and systems function as intended, aligned with regulatory standards, while collaborating with product managers, RTEs, developers and stakeholders to empower teams to manufacture and deliver high‑quality pharmaceutical products.

The role requires 5+ years of CSV experience in a regulated Life Sciences environment, strong knowledge of FDA CFR Part 11, HIPAA

Formación

• Bachelor's degree in computer science, information systems or 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.
• 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.

Responsabilidades

• 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, analyse 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

Conocimientos

CSV validation expertise

Regulatory knowledge (FDA CFR Part 11,

Cloud platforms (AWS, Google Cloud)

ITIL V3/V4

Test automation

Stakeholder management

Educación

Bachelor's degree in computer science / information systems

Herramientas

ServiceNow

AWS

Google Cloud

JIRA

Descripción del empleo

Roche is seeking a Computer System Validation Lead to oversee compliance and validation of digital solutions in CGT. You will ensure software and systems function as intended, aligned with regulatory standards, while collaborating with product managers, RTEs, developers and stakeholders to empower teams to manufacture and deliver high‑quality pharmaceutical products.

The role requires 5+ years of CSV experience in a regulated Life Sciences environment, strong knowledge of FDA CFR Part 11, HIPAA