PV Manager QA - GSK
Kathy Willson, B.Sc. (Hons), Dip. RQA
Kathy is a Manager in Pharmacovigilance QA at GSK. Kathy has over 20 years experience in the pharmaceutical industry with GSK and CROs. She achieved the Diploma in Research Quality Assurance in 1996. Kathy started off working in a GMP laboratory, then 6 years auditing preclinical activities including clinical laboratories, then another 8 years performing audits in GCP. Six years ago, she joined the newly formed Regulatory Affairs QA department at GSK where she helped build up a programme of global audits for Regulatory Affairs including systems and affiliates. In 2016, her role expanded to include Pharmacovigilance audits. Three years ago, she created the Research Quality Assurance (RQA) Regulatory Affairs Working Party because of her interest in finding out what other companies are doing with regards to auditing Regulatory Affairs. The Working Party are currently working on a guidance document for auditors.