Bruce Vernon (Qualified Person)MSc, CBiol, MIBiol, FCQI, FIBMS Tel: Office +44 (0)131 445 2817Tel: Mobile +44 (0)7903 831 480Email: brucevernon@vyvo.org.ukWeb: www.vyvo.netVersatile biopharmaceutical product development, regulatory and quality systems consultant with wide ranging experience. An Immunologist by training, Chartered Biologist and Qualified Person, Bruce gained his Master’s degree in 1995 whilst working with the UK Blood Transfusion Service (BTS). Initially training in Medical Laboratories and working abroad as technical advisor to the Nepal Red Cross BTS. Bruce has 30 years experience within GLP/GMP licensed facilities (FDA/MHRA), the last 10+ years at senior management level, within the biotech/pharma sector. During this time Bruce has gained extensive, specialist experience in biologicals and biotech manufacture, including R&D, Quality Control/Assurance, Regulatory and Production management posts, culminating in the post of Global Head of Quality and Site Manager at the sole manufacturing site for one of the fastest growing biotech companies in Europe. In this and previous roles Bruce was the main point of contact for European and US regulatory bodies.He has broad experience in the manufacture and control of both terminally sterilised and aseptically prepared sterile pharmaceuticals and biosimilars, including mammalian and bacterial cell derived products and viral production. Bruce has particular expertise in product development and the application of GMP to the manufacture and control of clinical trial materials. Bruce is eligible to act as a Qualified Person under the permanent provisions of Directive 2001/82/EC and 2001/83/EC, therefore eligible to act as QP for both licensed and investigational medicinal products and is a Chartered Biologist and Member of the Institute of Biology (CBiol MIBiol). He is also Fellow of the Chartered Quality Institute (FCQI) and Fellow of the Institute of BioMedical Sciences (FIBMS).Specialties: Strategic product development support, regulatory affairs advice and management, locum qualified person and quality systems compliance analysis and upgrade