Jim Dougherty
About Jim Dougherty
Jim Dougherty is the Director of Life Sciences at Clarkston Consulting with over 27 years of experience in quality and compliance in the pharmaceutical, biologics, and medical device industries.
Company
Jim Dougherty is currently a Director at Clarkston Consulting, where he has been employed since 2003. His role includes assisting FDA-regulated companies in developing and implementing quality systems. With over 11 years of consulting experience, he has broadened his expertise in the life sciences sector through his work at Clarkston.
Title
Jim Dougherty holds the title of Director, Life Sciences at Clarkston Consulting. His work focuses on providing guidance and strategies to companies, especially in areas related to quality and compliance, and helping them address regulatory enforcement actions.
Education and Expertise
Jim Dougherty achieved his MBA from the University of North Carolina at Greensboro and a B.S. from the University of Maryland. He has amassed over 27 years of experience in quality and compliance within the pharmaceutical, biologics, and medical device industries. His practical approach ensures that companies can solve complex technical and compliance issues from the lab bench to the boardroom.
Background
Jim Dougherty's career in quality engineering and management includes notable positions at Bristol Myers Squibb (ConvaTec) and Becton Dickinson. At Bristol Myers Squibb, he worked from 1991 to 2003, focusing on QA Engineering & Management. Prior to that, he was a Senior Quality Engineer at Becton Dickinson from 1987 to 1991. Each role honed his skills in quality and compliance.
Achievements
Jim Dougherty has outlined the challenges associated with the transition from clinical to commercial operations. He has detailed strategies to ensure a successful GxP commercial launch, demonstrating his ability to guide companies through the nuances of regulatory landscapes. His collaborative approach strengthens the quality systems of FDA-regulated companies, addressing key regulatory challenges.