Kathy Zielinski
Roche
Senior Principal – AI/ML Global Compliance Lead
Kathy brings more than 15 years of experience in providing leadership in CSV testing activities through the coordination of computerized systems validation activities, software testing and evaluation of software applications utilizing waterfall and Agile frameworks.
Prior to joining Roche Kathy was working in a number of Pharma organizations, including CROs, Generic Pharma and Roche Patient Support partners where she led csv teams in ensuring SDLC of bespoke and COTS systems meet GxP compliance expectations.
In 2019, Kathy joined Roche PTQE Audit team, where she has served as the Global Quality Expert for Computer Systems. She was responsible for defining the strategy for auditing computer systems to ensure a consistent, efficient & risk-based approach to risk identification. Kathy maintained full strategic responsibility for the computer systems audit program within GMP Compliance Audit.
Kathy has been involved in several Roche global Data Integrity initiatives, including the development of a new holistic approach to Data Integrity as well as Roche Digital Transformation, leveraging her knowledge in agile methodologies as a Certified Scrum Product Owner and Certified Scrum Master.
In 2021, Kathy joined Roche Digital Quality Team where she assumed the role of Compliance Intelligence Lead. She collaborates closely with technology and analytics teams in the Roche PT Data & Analytics Hub and PT Excellence 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 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 involved in numerous AI Projects across Roche – internal and external, supporting ML solutions implementations such as NLP-ML, CNN or GenAI.
Kathy is an active member of ISPE, working in GAMP AI SIG and PDA organizations focusing on Pharma 4.0 aspects.
Prior to joining Roche Kathy was working in a number of Pharma organizations, including CROs, Generic Pharma and Roche Patient Support partners where she led csv teams in ensuring SDLC of bespoke and COTS systems meet GxP compliance expectations.
In 2019, Kathy joined Roche PTQE Audit team, where she has served as the Global Quality Expert for Computer Systems. She was responsible for defining the strategy for auditing computer systems to ensure a consistent, efficient & risk-based approach to risk identification. Kathy maintained full strategic responsibility for the computer systems audit program within GMP Compliance Audit.
Kathy has been involved in several Roche global Data Integrity initiatives, including the development of a new holistic approach to Data Integrity as well as Roche Digital Transformation, leveraging her knowledge in agile methodologies as a Certified Scrum Product Owner and Certified Scrum Master.
In 2021, Kathy joined Roche Digital Quality Team where she assumed the role of Compliance Intelligence Lead. She collaborates closely with technology and analytics teams in the Roche PT Data & Analytics Hub and PT Excellence 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 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 involved in numerous AI Projects across Roche – internal and external, supporting ML solutions implementations such as NLP-ML, CNN or GenAI.
Kathy is an active member of ISPE, working in GAMP AI SIG and PDA organizations focusing on Pharma 4.0 aspects.