Computer System Validation Lead for Cell & Gene Therapy

F. Hoffmann-La Roche AG; Madrid; Presencial; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Roche in Madrid is seeking a Computer System Validation Lead to oversee the validation and compliance of our digital solutions within CGT. You will ensure that software, systems, and processes function as intended and meet regulatory standards.

You will collaborate with product managers, RTEs, software developers, system owners, and stakeholders to enable teams to manufacture and deliver high-quality pharmaceutical products.

Formación

• Bachelor's degree in computer science, information systems or a related study
• 5+ years of relevant experience in Validation/CSV in a regulated life sciences environment
• Advanced expertise in Computer Systems Validation (CSV) with regulatory understanding (FDA CFR Part 11, GDPR, GxP)

Responsabilidades

• Strategy & Validation Execution: formulate and deploy validation strategies for digital solutions and document validation activities.
• Risk Management & Regulatory Compliance: perform risk assessments and ensure data integrity and GMP compliance.
• Qualification & Core Testing: collaborate with QA SMEs to execute qualification benchmarks and tests.
• Process Improvement & Leadership: advance validation methodologies, tooling, and systems.
• Application Ownership: act as System Owner for CGT digital landscape applications.

Conocimientos

Leadership & Problem Solving

Stakeholder Management

Team Collaboration & Mentorship

English Fluency

Cloud Platforms

ServiceNow

ITIL

Educación

Bachelor's degree in computer science or information systems

Herramientas

AWS

Google Cloud

ServiceNow

ITIL v3/v4

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, 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.

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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.