With over 30 years of experience in quality, regulatory affairs, regulatory compliance, and operations within the pharmaceutical, medical device, food, dietary supplement, and cosmetic industries, Thomas Padula is a seasoned professional committed to business ethics, team collaboration, and product integrity. Thomas excels in technically demanding environments and has a proven track record of leading ISO 9001 certification, facilitating FDA readiness, and overseeing document control compliant with various regulations.
Thomas specializes in FDA and Quality Systems remediation, including regulatory responses to 483s, Warning Letters, and Consent Decrees. They have led and supported investigation and CAPA teams, contributed to PAI and FDA Product Approval initiatives, and promoted collaboration for efficient operations at all levels. Thomas’s key competencies include regulatory strategy, supplier compliance management, FDA remediation, audit preparedness, regulatory submissions, aseptic processing, environmental monitoring, and training with digital tools.
Throughout their career, Thomas has held significant roles such as Vice President of Regulatory Compliance at Schiff & Company, Inc., Director and Site Head of Quality at Unette Corporation, Inc., and Director of Operations at Hershey Import Co. Thomas has also worked in various capacities at The Estee Corporation, Globe Products Co. / Tyson Foods, Private Formulations Pharmaceutical Co., Inc., Primo Pharmaceutical Labs, Inc., and Mallinkrodt Nuclear Pharmaceutical Co., Inc.
Thomas holds a Bachelor of Science degree in Biological Sciences from Fairleigh Dickinson University and an FDA Better Process Control School Certification from Pennsylvania State University.