Gillian Birnie, the Owner and Operator of Clinical Quality First, is a Scottish national who transplanted to North Carolina in 2014 and became a permanent US resident in 2016. Gillian permanently relocated back to her native Scotland in 2022 and lives in North Edinburgh with her daughter and various pets and is a huge animal lover. Gillian also owns horses and rides when she's not working and parenting!
After graduating in 1996 with a BSc in Biological Sciences, Gillian worked for 8 years' in Preclinical Quality Assurance, auditing a variety of preclinical studies. Following this, Gillian spent 7 years' working for a global QA Consultancy group based out of Edinburgh, and gained a vast range of experience in multiple areas supporting preclinical and clinical organizations with creation of bespoke Quality Management Systems aimed primarily at compliance with Good Laboratory and Good Clinical Practice, performing all types of preclinical and clinical audits across the globe, from the USA to Japan, and authoring and delivering supporting training courses. Gillian then worked in Leadership positions for prominent Clinical Research Organizations within QA and Compliance, and notably has driven the configuration and implementation of 3 electronic Quality Management Systems, and provided validation expertise and support with the implementation of electronic Trial Master File systems, electronic signature systems and other non-QA centric systems.
