Gary Bird
About Gary Bird
Gary Bird Executive Vice President – Quality and Regulatory Affairs
Gary Bird holds the executive role of Vice President of Quality and Regulatory Affairs. In this capacity, he leverages over 30 years of experience in the pharmaceutical and biotechnology sectors. His responsibilities include overseeing regulatory compliance and quality system analysis, ensuring adherence to FDA standards, leading teams, and managing vendor relations. Bird's extensive background equips him with the expertise to maintain stringent quality controls and regulatory frameworks within the industry.
Gary Bird Education and Expertise
Gary Bird earned his Ph.D. in Entomology and Biochemistry from Mississippi State University. Across his career, he has developed a profound expertise in regulatory affairs, quality system analysis, FDA compliance, team leadership, and vendor relations. His academic and professional background positions him as an authority in the field, particularly regarding biopharmaceutical products' manufacturing practices and regulatory frameworks.
Gary Bird Background in Pharmaceutical and Biotechnology Industries
With over three decades in the pharmaceutical and biotechnology industries, Gary Bird has held notable leadership positions at key organizations such as the FDA (in both CDER and CBER divisions), Eli Lilly and Company, GTx Incorporated, and Geno Rx. He has also founded and led consulting firms PharmaConsult US and PharmaConsult Global, Ltd. His broad experience encompasses various constraints of the industry, particularly in regulatory and quality affairs.
Gary Bird ICH Activities and Negotiations
Gary Bird has played a significant role in the International Conference on Harmonization (ICH) negotiations. He has represented both the FDA and the industry in discussions concerning five different Quality topic areas. This involvement highlights his deep understanding of harmonizing international regulatory standards and practices, crucial for ensuring quality across global pharmaceutical products.
Gary Bird Lectures and Training Courses
Gary Bird has authored and delivered numerous lectures and training courses focused on various aspects of biopharmaceutical manufacturing practices. Some key topics he has covered include best manufacturing practices for biopharmaceutical products, an introduction to Good Manufacturing Practices (GMPs), biosafety, and stability issues of biopharmaceutical products. His educational contributions help foster a deeper understanding and adherence to regulatory and quality standards within the field.