Richard Smalley MSc C.Chem FRSC a highly experienced GxP and Quality Consultant, providing QP, RPi and RP services across pharmaceutical, unlicensed medicine, active substance and medical device environments. He brings extensive operational and strategic expertise across a wide range of dosage forms and international GxP requirements, supporting clients with both urgent quality challenges and longer-term improvement programmes. Richard has strong experience in inspection action remediation, significant change management, product quality and facility improvement, auditing, training, supplier management and risk-based quality oversight.
A proven global leader, Richard has successfully driven organisational, GMP/GDP, remediation and continuous improvement initiatives, helping businesses strengthen compliance, improve performance and embed sustainable ways of working. He is proficient in recall handling, regulatory inspection hosting, gap analysis, US PAI preparation, remediation implementation, improvement planning and liaison with regulatory authorities. His experience also includes managing supply chains, distribution networks, supplier relationships, validation activities, sub-contractor management and customer interfaces, with a practical focus on compliance, efficiency, commercial awareness and business continuity.