Tracy Moore is an accomplished quality professional with over 32-year experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level/status.
During her 10 years as a GMP Inspector Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities.
Tracy set up the MHRA's inspector academy in 2020 which allowed for an efficient accreditation of MHRA inspectors and assessed Member States inspector's competence through the Joint Audit Programme for EU.
Prior to the MHRA, Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles covering a wide range of sterile and non-sterile product dosage forms. In addition to this, she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers.