Computer System Validation Lead for Cell & Gene Therapy

Roche Holding AG; Madrid; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Roche Holding AG sucht eine erfahrene Lead-Position im Bereich Computer System Validation (CSV) im CGT-Umfeld. Sie überwachen die Validierung digitaler Lösungen, stellen regulatorische Konformität sicher und arbeiten eng mit Produktmanagern, Entwicklern und Stakeholdern zusammen, um hochwertige pharmazeutische Produkte zuverlässig herzustellen.

Sie bringen 5+ Jahre CSV-Erfahrung, Kenntnisse FDA CFR Part 11, HIPAA, GDPR, GMP mit und beherrschen Cloud-Plattformen wie AWS/Google Cloud sowie

Formación

• Bachelor's degree in computer science or related field.
• 5+ years as Validation/CSV expert in global regulated environments.
• Advanced expertise in CSV principles, documentation, and GMP practices.
• Regulatory standards including FDA CFR Part 11, HIPAA, GDPR, and current GxP documentation.
• Experience with cloud platforms (AWS, Google Cloud) and ServiceNow.
• ITIL v3/v4 knowledge.
• Prior knowledge of cell & gene therapy or pharmaceutical supply chain preferred.

Responsabilidades

• Strategy & Validation Execution: Formulate and deploy validation strategies for CGT digital solutions with comprehensive protocols.
• Risk Management & Regulatory Compliance: Conduct risk assessments and ensure data integrity and GMP compliance.
• Qualification & Core Testing: Collaborate with QA SMEs for qualification benchmarks and testing.
• Process Improvement & Leadership: Advance validation methodologies, tooling, and systems.
• Application Ownership: Act as System Owner for assigned CGT software applications.

Conocimientos

CSV Principles

GxP Docs

Regulatory Standards

Cloud Platforms

ServiceNow

ITIL

Life Sciences

Leadership

English Fluent

Educación

Bachelor's degree

Herramientas

AWS

Google Cloud

ServiceNow

Descripción del empleo

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die 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.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.