Kirstie Kay

Kirstie Kay (formerly Kirstie Young) has over 30 years of work experience in quality assurance and management roles within the medical device and pharmaceutical industries. Kirstie is currently serving as the Lead Quality Systems Manager at Elvie, where they have validated and implemented a new EQMS, maintained the QMS to ISO13485:2016 Medical Devices and MDSAP standards, and co-hosted regulatory audits. Prior to that, they were the Head of Quality at TrakCel Ltd. from 2017 to 2020, where they validated and implemented a new EQMS, oversaw the QMS aligned with ISO9001:2015 and GAMP 5, and conducted validation activities including computer software validation.

From 2006 to 2017, Kirstie held multiple roles at BBI Solutions, including Site Lead of the Blaenavon site, where they managed personnel and ensured production outputs met quality standards. Kirstie also served as the Site Compliance Manager, responsible for compliance activities, quality assurance and control, regulatory affairs, and employee health and safety. Additionally, they were the Quality Control Manager, overseeing testing and inspection of raw materials and rapid test products, and implementing ISO-2859 sampling plans.

Earlier in their career, Kirstie worked as the Quality Assurance Manager at Biozyme Laboratories from 1999 to 2006, responsible for the Quality System, Quality Control, and release of Active Pharmaceutical Ingredients. Kirstie implemented a new QMS to meet FDA and ICH Q7A requirements. Prior to that, they served as a Principal Scientist at Ortho Clinical Diagnostics from 1991 to 1999, specializing in HRP Conjugate manufacture, trouble-shooting, and process transfer.

Kirstie Kay, formerly known as Kirstie Young, obtained their Diploma in Quality Assurance from Howells School Llandaff. No further information regarding their education history is provided.