Kathy Zielinski (She/her)

Senior Principal Global AI/ML Compliance Lead

Hoffmann-La Roche

Kathy Zielinski serves as a Senior Principal, AI/ML Global Compliance Lead at Roche. Drawing on over 15 years of expertise within the Pharmaceutical industry, Kathy leads the critical area of AI & GenAI GxP Validation and software testing, utilizing both waterfall and Agile methods.
At Roche, Kathy’s influence is evident in several key areas. She has been involved in Roche’s Data Integrity and Digital Transformation initiatives as well as in establishing the foundational principles for Data and Analytics Governance. Her collaboration with the Roche PT Data & Analytics Hub specifically emphasizes her role in enhancing GxP compliance.
A recognized leader in advancing Pharma 4.0, Kathy was responsible for managing the development and implementation of Roche’s AI and GenAI GxP Validation Frameworks. This leadership extends to the regulatory landscape, as she is actively involved in discussions with Health Authorities regarding the GxP Validation Approach for AI, GenAI and Agentic AI systems. Highlighting her continuous commitment to compliance innovation, she is also involved in current discussions focused on making Agentic AI GxP compatible, utilizing a modern, risk-based approach.
Kathy actively contributes to AI projects and advancements (contributor to ISPE GAMP AI Guide) in the field through organizations like ISPE and PDA.