Mark Matis

Mark Matis

Mark Matis

Principal Consultant

Mark draws on 23 years of diverse experience in project management, Information Technology Quality Systems, Consent Decree, Data Reliability and Data Integrity, Business Analytics and Process Improvements, Quality Assurance and Quality Control and cGMP auditing. He assists clients in regulatory strategy, development, and compliance efforts to ensure robust quality programs and successful regulatory development and maintenance of pharmaceutical, biologic, biopharmaceutical and medical device products, laboratories and facilities.

Mark utilizes his broad background to assess compliance issues and develop effective, efficient robust and comprehensive systems to ensure regulatory compliance. He assists companies in ensuring regulatory documentation is adequately translated, implemented and maintained in laboratory operations and Information Technology based support in the FDA regulated environment.

Work Experience

Prior to joining Parexel, Mark was a Manager of Computer System Validation at a medical compressed gas company. He also held positions as a Senior Vice President of Operations of a pharmaceutical training software development company, Director of Quality at an environment analytical laboratory, and Analytical Chemist for commercial environmental analytical testing laboratories.


Mark holds a B.A. in Biology and Chemistry from Franklin Pierce University, New Hampshire.

We are always available for a conversation.