Gayla Smith has more than 30 years of experience in the pharmaceutical industry - human and animal drugs and over-the-counter and prescription drugs. Her experience includes quality assurance and quality control operations, global new product development, regulatory affairs guidance and assessment, development, and implementation of current Good Manufacturing Practices (cGMP) systems, product technology transfers, and strategic planning. Gayla has extensive experience in the development, implementation, and management of validations for laboratory testing, laboratory and manufacturing equipment, water systems, equipment cleaning, packaging, and product manufacturing processes. She has designed, coordinated, and written the Chemistry, Manufacturing, and Control (CMC) sections of many drug product submissions.
Gayla has quality assurance expertise in the production of solid dosage, powders, and liquid product forms. She has managed post-approval regulatory submissions (Change Being Effective and annual reports). She has reviewed and approved product advertising and promotional materials prior to submission to regulatory agencies, included the training of sales and marketing teams on compliance. Gayla has directed all quality assurance operations related to standard operating procedures, batch record reviews and releases, test method reviews, product and component inspections and releases, and reviewing, responding, tracking, and reduction of customer complaints. She has experience in supplier management – ingredients and packaging supplies, effectively improving the quality of the drug products and consistent manufacturing quality.
She has held various leadership roles in quality control, quality assurance, domestic and international technical project teams, marketing compliance, and auditing. She has provided oversight of domestic and international contract manufacturing organizations used to produce clinical, pre-approval, and commercial drug products, focusing on the development of strong partnerships. Gayla has served as the team leader in providing accurate and timely responses to CMC deficiency letters received from FDA and the Center for Veterinary Medicines during pre- and post- approval stages. Gayla has managed and trained employees in various Quality Assurance, Quality Control, and commercial manufacturing and packaging operations. She has worked with human resource departments to re-organize Quality Assurance departments after major company downsizings.
She has worked for Bristol-Myers Squibb, Wyeth Pharmaceuticals, Synthon Pharmaceuticals, Novartis Animal Health US, and BioDelivery Sciences International in Quality Assurance, Quality Control, product development, and regulatory compliance. Prior to working in the pharmaceutical industry, Gayla worked in the food industry, managing a microbiology laboratory, at GoodMark Foods, a subsidiary of General Mills.
Gayla serves as the Chairman of the Board for ATO, Inc., a 501(c)(3) nonprofit organization. She is one of the founders of this nonprofit, incorporated in 1997, whose purpose is to empower people from diverse socioeconomic backgrounds and ages worldwide by supporting and providing programs, activities, and services that enhance their lives.
Gayla holds an MBA from Meredith College – Raleigh, NC and a BS degree in Food Science from North Carolina State University – Raleigh, NC.