CGT CSV Lead: Validate Digital Systems & GMP Compliance

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

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.