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 / Incentivos • 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 •

📌 Ai/Ml Compliance Lead (Madrid)
🏢 Roche
📍 Madrid