Falguni Modi
About Falguni Modi
Falguni Modi is the Associate Director of Global Product Quality at Bristol Myers Squibb, with extensive experience in quality assurance and regulatory compliance across various pharmaceutical companies.
Title
Falguni Modi holds the position of Associate Director, Global Product Quality at Bristol Myers Squibb.
Current Role at Bristol Myers Squibb
Falguni Modi is currently serving as the Associate Director of Global Product Quality at Bristol Myers Squibb. In this capacity, Falguni has led the APQR process for Breyanzi and Abecma, ensuring that all regulatory deadlines were met. Furthermore, Falguni has launched and led the yearly biologic product reports (YBPR) process for cell therapy, coordinating activities with both internal and Canadian YBPR leads. The role also includes implementing and managing site APQR and CMO APQR processes, representing the company at CMO meetings to ensure compliance.
Previous Experience
Before her current role, Falguni Modi served as Senior Manager of Global Product Quality at Bristol Myers Squibb from 2020 to 2022. Prior to this, she worked at Merck as a Senior Quality Assurance Process Specialist for 8 months (2019-2020) and earlier held at Merck the position of Sr. Associate from 2007 to 2010. Falguni also contributed as Manager of Corporate and R&D Quality Assurance at Vertice Pharma from 2018 to 2019, and as Senior Q/A Documentation/Regulatory Compliance Specialist at CorePharma LLC for 8 years (2010-2018). Her other roles include senior and quality assurance positions at Impax Laboratories, Aptuit, Actavis (now Allergan), Teva Pharmaceuticals, and AccuMed Inc. Her career began at Torrent Pharmaceuticals Ltd, where she was a Senior Quality Assurance Specialist from 1991 to 1994.
Education and Expertise
Falguni Modi holds a Master of Business Administration (M.B.A.) in Pharmaceutical Management from Rutgers Business School, completed between 2016 and 2021. She also earned a Bachelor's degree in Pharmacy from Gujarat University, where she studied from 1987 to 1991. Her education, combined with extensive practical experience, has equipped her with deep expertise in quality assurance and regulatory compliance within the pharmaceutical industry.
Key Responsibilities and Initiatives
In her role at Bristol Myers Squibb, Falguni Modi has driven continuous improvement processes by leading cross-functional teams in lesson-learned sessions to optimize APQR results. She has been instrumental in developing and executing roadmaps for APQRs and providing regulatory guidance to ensure timely closure of change control, deviation, and CAPA deliverables in compliance with FDA regulations. Additionally, Falguni has contributed to the acquisition and visualization of data for APQR reports, maintaining preparedness for regulatory inspections and audits. She is also responsible for recruiting, hiring, developing, and training new hires in the Global Product Quality department.