Independent GxP quality consultant and contractor

Quickly becoming familiar with the Quality Management System (QMS) in a rapidly evolving pre-clinical and clinical Bioanalytical, Immunoassay and Biomarker field, I identified areas where operational activities had out-matured the QMS in place and made the changes necessary to bring quality improvements and operational efficiencies to the organisation. Following appointment to QA Manager for the European arm of the IDS bioanalytical division and the subsequent driving of process improvements and fostering of relationships with operational groups there was a dramatic turn around in the bioanalytical business in Manchester, evidenced by the successful completion of our routine inspection by our monitoring authority.Driving harmonisation of processes and procedures between ICON Development Solutions' European and US bioanlaytical sites was a fundamental aspect of this role, instigating the changes required to keep the business current.In addition to assuring compliance with GLP; GCP for clinical laboratories; and conformance with ISO 9001:2008 I had responsibility for the quality oversight of the Clinical Pathology and safety testing laboratory operating in compliance with GCP and in conformance with ISO 17025:2005.During my time with ICON, I developed the QA function from a single person, to a widely experienced group with 5 team members.In addition to my responsibilities in our bioanalytical division I provided consultative QA services to ICON's Phase I facilities in Manchester including IMP manufacturing to GMP in its pharmacy and other clinical supporting services.

Having gained insight into the QMS within ICON Development Solutions I continued to drive improvements by becoming involved in qualification audits of suppliers and subcontractors. This position also brought with it responsibility for the QA operations at the site in Manchester and subsequent reporting of issues and KPI to global management.

Joining ICON Development Solutions as an experienced QA auditor I immediately became involved in auditing bioanalytical contributing reports for clinical and toxicology studies.

In 2008 I was placed into the position of QA Team Leader for the General Toxicology group. In this position I orchestrated between 5 and 12 permanent and consultant QA auditors. Development and training of personnel was an integral component of this position. Organisation and hosting of, as well as presentation at client audits was a frequent occurrence, as was co-hosting of a number of routine regulatory monitoring authority surveillance audits. As a senior member of the QA department I interacted closely with the Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) for clinical Laboratories QA groups. During my time as QA Team Leader my greatest challenge was having to turn around a significant and persistent backlog in the QA auditing workload. Driving pragmatic scheduling and improvements in communication between the operational teams and the QA group, this backlog diminished, resulting in vastly improved client relationships and repeat business.

In 2007 I was promoted to the position of Lead Auditor within the Toxicology division of Charles River Laboratories. Whilst providing general regulatory advice and guidance to Study Directors, I specialised in regulatory aspects of multi-site studies.

Leaving biochemistry research behind, I moved into Quality Assurance in 2005 for Charles River Laboratories (formerly Inveresk Research), near Edinburgh, Scotland. Auditing to Good Laboratory Practice (GLP) regulation I began working in the analysis of agrochemicals for the field trials division of the business. I soon moved into the pre-clinical toxicology group investigating possible toxicological effects of novel pharmaceuticals in a number of species. Contributing disciplines included formulation analysis, pathology, clinical pathology, telemetery and pharmacokinetic evaluation.

Academic research into the biochemical characteristics and cell migration stimulating behaviour of a novel protein in cancer and wound healing in vitro models