Mr. Warpula will oversee all aspects of quality at Intrinsic Imaging including the administration of Intrinsic Imaging’s ISO certified quality management system – the most comprehensive and sophisticated QMS in the imaging core lab industry.
Bolton, MA, San Antonio, TX, March 13, 2017
Intrinsic Imaging LLC, an FDA audited, ISO certified imaging core lab specializing in providing imaging core lab services for clinical trials announces today the appointment of Mr. James Warpula as Vice President of Quality Assurance and Compliance.
In his role at Intrinsic Imaging, Mr. Warpula will oversee all aspects of quality of imaging core lab services on Phase I, II and III Clinical trials as well as Class I, II and III Medical Device trials. Mr. Warpula’s oversight includes the administration of Intrinsic Imaging’s ISO certified quality management system – the most comprehensive and sophisticated QMS in the imaging core lab industry.
Mr. Warpula has over 25 years of experience within international pharmaceutical, biotechnology and medical device organizations and he is a certified quality auditor of the American Society of Quality (ASQ) and a certified ISO lead auditor.
Throughout his career, Mr. Warpula has held strategic quality leadership roles within the biopharmaceutical and medical device industries. Prior to joining Intrinsic Imaging, Mr. Warpula was most recently Senior Manager of Global Quality Assurance at Waters Corporation (NYSE: WAT) which holds worldwide leading positions in analytical instrumentation. At Water’s Corporation, Mr. Warpula implemented several key improvements which demonstrated success in the areas of clinical product quality and manufacturing, quality system implementation, post-market surveillance and technical product management.
Mr. Warpula was previously Associate Director of Quality Operations at Baxter where he had direct responsibility for quality operations supporting Phase III clinical trials and subsequent GMP manufacturing of an OBI-1 Hemophilia drug. Prior to Baxter, Mr. Warpula served as Associate Director, Quality Systems and Compliance at Genzyme Sanofi. While at the company, he directed several quality initiatives that led to continuous improvement and compliance of quality systems for late stage clinical trials and cGMP commercial drug manufacturing and final drug product release.
“As an industry veteran, Mr. Warpula brings a wealth of quality management experience to Intrinsic Imaging,” said Todd A. Joron, BSc., MBA, President and COO of Intrinsic Imaging. “We look forward to his contributions and the extensive experience and expertise he brings to Intrinsic Imaging.”
Mr. Warpula holds a Bachelor of Science degree in Business Administration from Becker College, Massachusetts.
About Intrinsic Imaging LLC
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than seventy board-certified fellowship trained radiologists, robust and scalable clinical imaging technologies and its ISO certified quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world. For more information, please visit www.IntrinsicImaging.com