Consultant, President of Mark Tucker, LLC

Mark Tucker, PhD

Mark Tucker is the Founder and President of Mark Tucker, LLC, a consulting firm specializing in Inspection Management and GMP training. Mark has over 15 years experience in the area of Pharmaceuticals, including experience at FDA as an Investigator, Analyst, Compliance Officer and finally Investigations Branch Director.

Mark also worked at Genentech, a leading biotech manufacturer, progressing from Associate Director to Senior Director while leading both Inspection Management and GMP Compliance audit functions.

Mark is an active member of various industry associations, including ECA, PDA, RAPS and ISPE, and is a member of the FDA Alumni Association. He has presented on FDA Inspections and Inspection Management in the US, Europe and China.

Mark holds a Life Sciences BS from the University of Nebraska – Lincoln and a PhD in Biochemistry from William Marsh Rice University in Houston, Texas.

He is author or co-author of the following chapter of GMP Compliance Adviser:

  • 1.O Regulatory compliance – how to optimize