Dr. Zainab Fatima

Neuroscientist & AI SME

Dr. Zainab Fatima is a neuroscientist and AI leader focused on human-centered digital transformation in regulated healthcare environments. With a PhD in cognitive neuroscience and deep expertise in applied AI, she bridges advanced technology and real-world adoption by designing solutions that align with how people make decisions and operate under pressure.

She leads enterprise-scale digital initiatives across medical, commercial, and compliance teams, and is recognized for building organizational capacity in AI while fostering cultures that enable responsible, sustainable innovation.

Shayli Babazadeh

AI Product Owner, Sanofi

Shayli Babazadeh is an AI Product Owner at Sanofi, where she leads the development of AI‑driven solutions to advance pharmaceutical manufacturing. Her work focuses on modernizing operations through Predictive Maintenance, the strategic application of Generative AI, and Data Quality excellence. With a talent for translating complex technical needs into practical, user‑centric tools, Shayli empowers manufacturing operators and teams to shift from reactive problem‑solving to proactive, data‑informed decision‑making. She is passionate about enabling the workforce with technology that enhances reliability, efficiency, and operational excellence.

Kathy Zielinski

Senior Principal - Global AI/ML Compliance Lead, 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 and Generative 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.

Flora Suen

Chair, Women in Pharma (WIP)

Flora is a Quality Leader with 13+ years of experience in the pharmaceutical, medical device and biologics industries. Flora has provided general GMP consulting guidance and oversight related to commercial operations and clinical trials. She has diverse experience from managing quality departments, to quality control, to supporting R&D and manufacturing departments.

In her current role as Manager, Compliance Services at Q&C Services, she adept at dealing with large continuous improvement initiatives, training, auditing, liaising with regulators on behalf of clients, and proposing solutions tailored to each client. Internally, Flora enjoys coaching/mentoring team members and spreading the knowledge/expertise. ...read more

Susanna Jacob

WIP Committee

Susanna is an accomplished Quality leader with strong track record navigating challenging, regulated environments. Equipped with a Master’s in Science, her career began at Sanofi where she has held progressive roles in Quality Assurance.

She has provided Quality oversight to several biopharmaceutical manufacturing departments, and is well versed in GMPs as well as both local and international regulatory requirements. In her current role at Sanofi, she is instrumental in supporting local and international market releases and optimizing Quality systems used for batch release. ...read more

Mehreen Rizman

WIP Committee

Mehreen is an accomplished leader with 15 years of dynamic experience across the pharmaceutical industry. Holding a Chemical Engineering degree, her expertise spans in vast areas including QC labs, batch documentation, manufacturing investigations, continuous improvement initiatives, and now Capital Engineering.

As a Capital Engineering Manager at Apotex Inc., she takes charge of new equipment procurement projects for solid and liquid dose and packaging facilities. Mehreen also plays a vital role in facility construction efforts, ensuring these projects directly support new business initiatives and lead to tangible enhancements in manufacturing productivity and efficiency. She is known for her unwavering ability to lead projects from conception to completion, consistently hitting challenging timelines, and fostering exceptional collaboration among cross-functional teams. ...read more