Gary Bird is an accomplished Senior Executive and Consultant with more than 25 years of success in the pharmaceutical and biotechnology industries. Leveraging extensive experience ensuring compliance at the FDA and in the development and commercialization of new pharmaceuticals, he is a valuable asset for growing pharmaceutical companies seeking advice on product development, quality control, clinical trials, and go-to-market strategy.
His broad areas of expertise include regulatory affairs, quality system analysis, FDA compliance, team leadership, continuous improvement, and vendor relations.
Throughout his executive career, Gary has held leadership positions at pharmaceutical and biotech-related organizations including the Food and Drug Administration (CDER and CBER). Eli Lilly and Company, GTx Incorporated, and his consulting firms PharmaConsult US and PharmaConsult Global, Ltd. He represented both FDA and Industry in the International Conference on Harmonization (ICH) negotiations.
He has been responsible for developing and overseeing a Corporate Quality System for all GXP compliance activities while ensuring continuous improvement in system reliability by creating and implementing a Corporate Quality Plan; overseeing all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) activities and ensuring their compliance with relevant laws and regulations, including creating a GCP audit program to monitor clinical trials conducted inside and outside of the US.
Gary holds a BS in Invertebrate Zoology and Chemistry and an MS in Invertebrate Zoology and Biochemistry from Memphis State University as well as a PhD in Entomology and Enzyme Biochemistry from Mississippi State University.
He has authored and delivered numerous lectures and training courses as part of his consultancy services on subjects including best manufacturing practices for biopharmaceutical products, introduction to GMPs, introduction to biosafety, and stability of biopharmaceutical products.