Dr.Thurloch O’Criodain is a Senior Quality Leader with 40 years’ experience spanning medical devices, pharmaceutical and biopharmaceutical quality operations.
Thurloch has worked for some of the world’s leading companies including Abbott Laboratories, Wyeth, Johnson & Johnson, and Novartis Pharma AG. His experience includes working at both local and corporate levels.
Thurloch served as the Regional Director of Quality for the EMEA region at Wyeth. While in this role, he managed 9 new product launches at European level. He also served as International Director of Compliance Auditing at Wyeth. In Novartis, Thurloch was responsible for quality operations across 14 drug product manufacturing sites. Thurloch went on to lead a number of international compliance remediation and improvement projects. He has successfully managed the preparation and execution of more than 20 FDA inspections in the last five years, of which 8 were pre-approval inspections leading to successful product launches.
Since leaving Novartis, Thurloch has been working independently to provide training and consultancy services to the pharmaceutical industry, working on three continents and with several different companies and organisations.
Thurloch has earned a Ph.D. from the National University of Ireland, as well as a post-graduate diploma in pharmaceutical manufacturing technology, which qualifies him to work as a Qualified Person in accordance with European regulations. He is a senior member of the American Society for Quality, and a member of the Parenteral Drug Association.
Key competencies include cGMP, Quality Assurance/Systems/Control, Compliance, International Product Transfer, Regulatory Strategy, Remediation Leadership, Special Process Validation, Validation Planning, ISO 9001 and ISO 13485