With more than 30 years of pharmaceutical, biotechnology, and medical device industry experience, Kelly Thomas is a senior Quality and Regulatory Compliance executive specializing in cGMP quality systems, inspection readiness, and operational excellence. Her expertise spans APIs, biologics, sterile and non-sterile manufacturing, medical devices, combination products, controlled substances, aerosols, and oral solid dosage forms.

Kelly has successfully led facility start-ups, global regulatory inspections, and quality transformation initiatives across FDA, EMA, MHRA, Health Canada, ANVISA, JP, TGA, IMB, and other international regulatory environments. She is recognized for building robust quality systems, strengthening supplier and contract manufacturing oversight, driving process and equipment validation programs, and leading complex investigations and technology transfers.