Kathy Zielinski (She/her)

Compliance Intelligence Lead

Roche

Compliance Intelligence Lead, Computer System Quality Chapter, PT Quality Fundamentals. She brings more than 15 years of experience in providing leadership in CSV processes coordinating validation activities, software testing and evaluation utilizing waterfall and Agile frameworks. Working in PT Global Audit team, she was responsible for defining the strategy for auditing computer systems to ensure a consistent, efficient & risk-based approach to risk identification.
In her current role, she collaborates closely with technology and analytics teams in the PT Data & Analytics and PTE to ensure GxP compliance of cutting-edge digital technologies (AI & Machine Learning) to surface relevant, predictive and actionable compliance risk insights from available internal and external data sources. In addition, she proactively expanded compliance teams’ data-driven capabilities and overall digital-savvy. She successfully completed a Machine Learning in Business at Rotman School of Management University of Toronto where she learnt business application of Machine Learning and its methodologies.
Recently she finalized the first Guidance Document for Roche PT related to best practices of Machine Learning Validation. She is an active member of the ISPE GAMP AI Special Interest Group.