Marion Mays

Vice President, Client Solutions and Quality Assurance

Marion has a wealth of experience leveraging the competitive advantage of managing records and the TMF in an audit-ready manner, having steered the development and implementation of regulated, enterprise-wide programs across organizations.  An industry leader in Information Management with over 25 years of experience in the Pharmaceutical industry.  An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the advancement of clinical outcomes.  Highly skilled in developing and implementing enterprise-wide programs and systems in regulated environments with proven record of success in technical problem solving.  In-depth experience with quality and compliance processes in the pharmaceutical industry including supporting organizations through major regulatory inspections with FDA, MHRA, EMA, and PMDA.  Experience in R&D, Clinical Research, Manufacturing, Quality Assurance, Records & Information Management, Quality Control, Operations, and Systems Implementation.

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Marion Mays