Kathy Zielinski

Kathy Zielinski is Senior Principal and AI/ML Global Compliance Lead at Roche, with over 15 years of pharmaceutical industry experience. She leads GxP validation and software testing for AI and GenAI using both waterfall and Agile methods. At Roche, she has contributed to Data Integrity, Digital Transformation, and Data & Analytics Governance initiatives, collaborating with the PT Data & Analytics Hub to strengthen GxP compliance. Kathy managed the development and rollout of Roche’s AI and GenAI GxP Validation Frameworks and engages with Health Authorities on regulatory approaches for AI and GenAI systems. She is also helping define strategies to make Agentic AI GxP compatible through a modern, risk-based approach. Beyond Roche, Kathy supports industry progress as a contributor to the ISPE GAMP AI Guide and an active member of ISPE and PDA.