Michael Girouard

Michael Girouard is Executive Director of Quality at Context Therapeutics and brings more than 20 years of quality and compliance leadership experience across the pharmaceutical, medical device, clinical research, and regulated manufacturing industries. Prior to joining Context, he held senior quality roles at Organon, where he supported the Merck spin-off, the development and implementation of R&D quality systems, pipeline and biosimilar programs, and global health authority inspections.

Michael's expertise spans quality oversight across GMP, GCP, GLP, and GVP environments, including pharmacovigilance, safety reporting, clinical operations, biostatistics, labeling, publications, medical affairs, vendor and CDMO/CMO management, and inspection readiness. He previously led quality systems initiatives at Adare Pharma Solutions and built a comprehensive Quality Management System (QMS) for a startup organization, supporting GMP operations, product launches, and successful FDA inspections.

Michael holds a Bachelor of Science degree from Temple University and is an ASQ Certified Quality Auditor as well as a Six Sigma Green Belt.