Responsible for Quality Assurance at Alimentiv since 2005, Karen has built the  QA department into an eight-member team that hosts agency inspections, conducts internal audits, assesses vendors and oversees QA for the organization.

Background

Karen spent 10 years at Eli Lilly in a variety of roles including Data Management, Clinical Monitor, Clinical Project Manager and Training Leader. She has been a member of the SQA since 2006 and was RQAP-GCP certified in 2009.

Achievements

Successfully hosted the FDA in 2017 with no 483 or verbal observations.

Ethos

“Kindness, patience and empathy are the most powerful tools in my tool chest.”