Kunjal Shah
About Kunjal Shah
Kunjal Shah is the Director of Global Quality at Bristol Myers Squibb, with extensive experience in quality management and compliance within the pharmaceutical industry.
Title at Bristol Myers Squibb
Kunjal Shah is currently serving as the Director Global Quality at Bristol Myers Squibb. She transitioned to this role from her previous position as Associate Director, Product Quality Management, a role she held from 2017 to 2020. Her responsibilities include overseeing global quality operations with a focus on maintaining high standards and ensuring product quality compliance across various markets.
Previous Industry Experience
Kunjal Shah has extensive experience in the pharmaceutical industry, having held multiple quality management positions at high-profile companies. Before her current role, she served as the Director of Quality Systems at The Janssen Pharmaceutical Companies of Johnson & Johnson from 2015 to 2017. She also held various directorial and managerial roles at Johnson & Johnson between 2010 and 2014, focused on compliance and quality systems. Furthermore, she worked at Baxter Healthcare Corporation as Manager, QA Compliance, for eight years and has experience as a QA Compliance Auditor at Celsis Laboratory Group and a Senior Scientist at Roche.
Education and Expertise
Kunjal Shah holds a Master of Business Administration (MBA) with a concentration in Pharma from Rutgers Business School, completed in 2023. She also earned a Master’s Degree and a Bachelor’s Degree in Microbiology, Biology, and Chemistry from The Maharaja Sayajirao University of Baroda. Her education laid a robust foundation for her comprehensive expertise in regulatory compliance, audits, and quality risk management within the pharmaceutical industry.
Achievements in Quality Management
Kunjal Shah has spearheaded several initiatives leading to significant improvements in quality management processes. She successfully led site inspections that resulted in approvals for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). By implementing phase-appropriate Good Practice (GxP) policies and Quality Risk Management (QRM) principles, she was instrumental in preventing regulatory sanctions. Her efforts in adopting digitalization and automation, including the use of Robotic Process Automation (RPA-BOTs), Artificial Intelligence (AI), and Machine Learning (ML), yielded substantial cost reductions and resource optimization.
Regulatory Compliance and Inspections
Throughout her career, Kunjal Shah has played a crucial role in managing regulatory decisions and ensuring compliance with various health authority inspections. She has hosted FDA and other health agency inspections with favorable outcomes, collaborated with manufacturing teams on Good Manufacturing Practices (GMPs), and conducted audits to uphold high-quality standards. Her proactive approach in monitoring product quality trends and presenting them at quality councils has ensured timely escalations and actions for continuous improvement.