Experteer Overview In this role you will lead Quality Assurance for AI/ML digital solutions in a GMP setting, shaping validation and compliance across cross-functional teams. You will partner with data science, software, and IT to deploy robust AI/ML systems that meet regulatory standards. Expect to identify and mitigate quality, security, and data privacy risks while driving CSV/CSA improvement. Your work will influence integral stakeholders and cultivate digital validation capability, advancing Roche’s mission to improve patient access to innovative therapies.Compensaciones / Beneficios
- Provide QA oversight and validation for AI/ML systems in a regulated GxP/GMP environment
- Collaborate with data science, software development, and IT to integrate AI/ML into business applications under CSV/CSA frameworks
- Author, review, and approve validation docs (plans, specs, architecture, test scripts)
- Identify and mitigate quality, security, and data privacy risks across the AI/ML lifecycle
- Align diverse stakeholders to compliant validation strategies for digital solutions




- Drive continuous improvement of CSV/CSA processes and integrate AI risk management frameworks
- Mentor colleagues across Digital Compliance and Quality to build capability in digital validationResponsabilidades
- BS/MS in Science, Computer Science, Engineering, or related field
- 5-7 years in a regulated pharmaceutical, biotech, or medical device environment
- Hands-on experience designing, validating, or implementing AI/ML systems (deep learning, NLP, LLMs, AI agentic workflows)
- Strong knowledge of FDA/EMA regulations, GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9/Q10
- Programming in Python or R; cloud platforms (AWS, Azure, GCP); MLOps for model governance
- Analytical and problem-solving skills with high autonomy
- Excellent communication and influencer abilities to build consensus across teams
- Commitment to Roche’s values of inclusivity, continuous learning, and accountabilityRequisitos principales
- equal opportunity employer

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