Marie Mathews
About Marie Mathews
Marie Mathews is the Associate Director of GXP External Engagement at Bristol Myers Squibb, with extensive experience in regulatory affairs and compliance within the pharmaceutical, biologic, and medical device industries.
Current Position at Bristol Myers Squibb
Marie Mathews currently holds the position of Associate Director, GXP External Engagement at Bristol Myers Squibb. Her role is based in New Brunswick, New Jersey, United States. Her position involves extensive collaboration within the pharmaceutical landscape to ensure compliance with GXP standards.
Previous Experience at FDA
Marie Mathews spent eighteen years working at the FDA in various capacities. She served as a Compliance Officer from 2011 to 2020 in Atlanta and from 2016 to 2020 in Silver Springs, Maryland. Prior to this, she worked from 1991 to 2000 as an Investigator/Consumer Safety Officer. Her roles at the FDA included performing inspections of Good Clinical Practices (GCPs) and Good Manufacturing Practices (GMPs).
Quality Assurance Roles at CDC and Emory University
Before her extensive tenure at the FDA, Marie Mathews worked in quality assurance roles. From 2008 to 2011, she was involved in quality assurance at the Centers for Disease Control. Prior to that, she worked for two years in quality assurance for the Institutional Review Board (IRB) at Emory University.
Educational Background in Regulatory Affairs
Marie Mathews earned a Master's degree in Pharmacy with an emphasis in Regulatory Affairs from The University of Georgia. Her educational background provided a strong foundation for her career in regulatory matters, compliance, and quality assurance within the pharmaceutical industry.
Expertise in Sterile Processing and Conferences
Marie Mathews has extensive experience in sterile processing within the pharmaceutical, biologic, and medical device industries. Additionally, she is a highly rated speaker at major GxP conferences, where she covers topics such as FDA policy, compliance, and mature quality cultures.