Lori F. Hirsch, JD Bristol-Myers Squibb

Lori Hirsch, Vice President, Regulatory Compliance and External Engagement Quality.  Lori leads the Regulatory Compliance and External Engagement Quality group which is responsible for developing and implementing a closed loop quality system for external regulatory engagement and internal regulatory compliance assessment and monitoring to ensure that the BMS company-wide integrated quality GxP management system is operating effectively and in compliance with current regulations and expectations; thereby ensuring proactive quality and compliance, risk identification, mitigation and communication.  This group supports the end to end GxP continuum and includes such areas as  our GMP/GDP auditing group, IT Quality Assurance, External Engagement , Data Integrity Center of Excellence and our enterprise-wide Compliance and Monitoring Group.  Lori joined BMS in January 2018 and prior to this, she served as Managing Counsel, Merck Manufacturing Division, and was a member of the Global Quality leadership team. Lori is an active participant in industry organizations and well-known to many regulators.  Lori received a Bachelor of Arts degree from Tufts University and a Juris Doctor degree from The University of Michigan Law School.