Kathy Zielinski is a Senior Principal and the AI/ML Compliance Lead at Roche. With over 15 years of distinguished experience within the pharmaceutical sector, Ms. Zielinski spearheads the strategic oversight of GxP validation and software testing for Artificial Intelligence, Generative AI, and Agentic AI. Her expertise encompasses both traditional waterfall and modern Agile methodologies, ensuring robust compliance in an evolving technological landscape.

Throughout her tenure at Roche, Ms. Zielinski has been a pivotal architect of the organization’s Data Integrity and Digital Transformation initiatives. She was instrumental in defining the foundational governance principles for data and analytics, and her ongoing collaboration with the Roche PT Data & Analytics Hub continues to fortify the company’s GxP compliance framework.

As a prominent leader in the advancement of Pharma 4.0, Ms. Zielinski directed the development and integration of Roche’s comprehensive GxP validation frameworks for AI and Agentic systems. Her leadership resonates globally through her active engagement with Health Authorities, where she advocates for modernized, risk-based validation approaches. Currently, she is at the forefront of industry discourse regarding the GxP compatibility of Agentic AI, driving innovation through rigorous compliance standards.

Ms. Zielinski is a dedicated contributor to the broader scientific community, notably serving as a contributor to the ISPE GAMP AI Guide (published July 2025). She maintains active professional engagement through leadership roles and contributions within the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).