Mark Lookabaugh

Mark Lookabaugh

Mark Lookabaugh

Principal Consultant

Mark provides GMP and QSR auditing and consulting services to Parexel clients worldwide.

Work Experience

Prior to joining Parexel, he served 30 years with the FDA. His career included work as an Analytical Chemist in the New England District laboratory, specializing in pharmaceutical chemistry. He performed Pre-Approval Inspections (PAIs) in the pharmaceutical and biotechnology industries in the US and overseas. He also served for 8 years as a Compliance Officer in the New England District Office, processing FDA enforcement actions in the 6 New England States. During this period, he managed several medical device cases and gained knowledge of the QSR and MDR regulations. In 2004, he was promoted to Director, Compliance Branch, with responsibility for oversight of all FDA enforcement activities in the New England District. He has published scientific papers in the Journal of Chromatography, and is the recipient of several FDA awards.

Education

Mark received a B.S. degree (Chemistry) with high honors from Worcester Polytechnic Institute, Worcester, Massachusetts

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