Sherri Hubby has over 20 years of Global Quality Assurance management, auditing and training experience with emphasis in the GCP and GMP area for vendors, and sites including inspection hosting experience for the (CRO)/Pharmaceutical/Biotech/Medical Device and IRB industry. Most recently, Sherri designed and developed a vendor risk assessment program, resulting in harmonization across 4 GxP areas. In addition, Sherri has an additional 9 years as an FDA inspector with emphasis in Bioresearch monitoring, drug and biologics inspections, eventually becoming a blood bank specialist and being invited to become a part of a nationwide expert investigation team due to significant blood bank findings resulting in a consent decree.

Over 16 yrs in the industry spanning both biopharmaceutical and CRO organizations with an emphasis on quality,clinical operations, process development and safety. His concentration over the past several yrs has been on the development of QRM systems, having just completed a QbD build at Gilead.