Experteer Overview
In this role you drive quality assurance for cutting-edge AI/ML digital solutions in a GMP environment at Roche. You will partner with data scientists, software and IT teams to validate and operate AI/ML systems that support GMP objectives. You mitigate quality, security, and data privacy risks across the AI/ML lifecycle while aligning validation strategies with global regulatory frameworks. You’ll influence stakeholders across units and foster capability in digital validation, contributing to Roche’s mission to improve patient care.

Compensaciones / Ventajas
• Lead QA oversight, validation, and compliant execution of AI/ML systems in a regulated GMP environment
• Collaborate with data science, software development, and IT to integrate AI/ML into business applications under CSV/CSA frameworks
• Create and approve validation documents (validation plans, specs, architecture, test scripts)
• Identify and mitigate quality, security, and data privacy risks across the AI/ML lifecycle




• Align diverse stakeholders to establish compliant validation strategies for digital solutions
• Drive continuous improvement of CSV/CSA processes and integrate AI risk management into quality systems
• Mentor colleagues in digital compliance and validation practices

Responsabilidades
• BS/MS in science, CS, engineering, or related field
• 5–7 years in a regulated pharma/biotech/medical device environment
• Hands-on experience designing/validating/implementing AI/ML systems in commercial settings
• Knowledge of FDA/EMA regulations, GAMP5, 21 CFR Part 11, Annex 11, ICH Q9/Q10
• Programming skills (Python, R) and cloud platforms (AWS, Azure, GCP) with MLOps for production governance
• Strong analytical, problem-solving, and communication skills
• Ability to work cross-functionally and influence stakeholders

Requisitos principales
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📌 AI/ML Compliance Lead (Madrid)
🏢 Roche
📍 Madrid