Peter joined the pharmaceutical industry in 1977, working for The Wellcome Foundation in the UK, spending seven years in biological QA and five years as a Clinical Research Associate and Study Manager. In 1989 he established the training function for the ex-USA Medical Division of Wellcome, including GCP SOP development and management. Following the Wellcome-Glaxo merger, Peter relocated to their USA R&D HQ in North Carolina to set up the U.S. Medical Operations training function. Returning to the UK in 1997, Peter joined Amgen’s European Development HQ to establish the European training function, involving him in the development and management of the company’s global GCP SOPs.
In 2004, Peter returned to the USA to join Pfizer’s Global R&D organisation as the Worldwide Head of SOPs and Training for Development Operations. In 2007, Peter relocated to the UK to lead Inspection Management, being responsible for the overall management of GCP, GLP, and pharmacovigilance (PV) inspections. His team had responsibility for analysis of audit and inspection trends, and monitoring the completion of CAPAs and commitments made to Regulatory Authorities as a result of inspections.
From November 2015, Peter worked for Merck Sharp & Dohme as the Head of Quality & Continuous Improvement within Global Clinical Trial Operations (GCTO). He established and maintained a robust Quality Management System (QMS) within GCTO, ensuring quality-by-design and a culture of quality are embedded in all aspects of clinical trial conduct. Managing a group of over 160 staff, he was responsible for management of SOPs, training content and strategy, clinical operations process improvements, regulatory GCP inspections, and CAPAs.
In May 2019, Peter set up his clinical quality consultancy to provide GCP services to the biotech and pharma industries.
During his career, Peter has developed numerous clinical operations (GCP) SOPs for a range of companies (from start-ups to multinational enterprises), has managed multiple GCP and PV inspections, has delivered training on a wide range of topics around the world, and has presented at external industry meetings. He has also published book chapters on competency-based training within the pharmaceutical industry.