CGT CSV Lead: Validation & Compliance Architect

Roche Holding AG

Madrid

On-site

EUR 90,000 - 130,000

Full time

14 days+

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Job summary

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

Qualifications

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.

Responsibilities

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.