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 global stakeholders and cultivate digital validation capability, advancing Roche’s mission to improve patient access to innovative therapies.
Compensaciones / Incentivos
• 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 validation
Responsabilidades
• 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 accountability
Requisitos pr
📌 AI/ML Compliance Lead (Madrid)
🏢 Roche
📍 Madrid