Computer System Validation Lead for Cell & Gene Therapy

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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 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, 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

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 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.

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

Who we are

A healthier future drives us to innovate. 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 global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.