About Tony King
What is there in common between the maintenance of a nuclear reactor
and the design of a lifesaving drug?
Quality Assurance
What is there in common between a former nuclear submarine engineer
officer and an effective Quality Assurance consultant?
Management Expertise
What do you get when you combine the experience of 25 years as an Engineer
Officer in the Royal Navy with 15 years of QA in North American healthcare
and other industries?
Tony King
Tony King, BSc, CEng, MIMarEST
Tony’s management, organizational and quality skills stem from 25 years as an Officer in the Royal Navy. For the majority of his naval career Tony worked as a Marine Engineer Officer in the submarine service. At sea, he was responsible for propulsion, control and power generation systems. Ashore he served in a variety of support roles, ranging from in-service maintenance management to new-build design review. Nuclear submarines were the cradle of Quality Assurance as we know it today.
Since emigrating to Canada in 1993 Tony has specialized in Quality Assurance for the Health Sciences sector, firstly in the medical device field and more recently in the pharmaceutical industry. During his nine years with one of the leading biotech companies in British Columbia he has obtained wide ranging experience in drug development and regulatory submissions. His hands-on management style enabled him to be a key player in achieving regulatory and quality compliance throughout the drug development cycle.
Tony holds a bachelor’s degree in marine engineering, a post graduate diploma in nuclear engineering and the UK professional designation of Chartered Engineer (C.Eng.). He is a member of the American Society for Quality (ASQ), the Regulatory Affairs Professionals Society (RAPS) and the Institute of Marine Engineering, Science and Technology (IMarEST).
Case History
Tony became the founding manager of the newly formed QA group of Inex Pharmaceuticals in May 2000. His prime task was to develop a quality system capable of supporting the company’s first New Drug Application (NDA). As well as the identification and creation of all the policies and procedures to define the system, this involved instilling a quality culture across all the teams involved in the product development – something that was alien to many, since the company had previously been research oriented. Tony oversaw the staged introduction of the quality system, with training of all appropriate staff, leading to implementation of the following functions: document change control; qualification of vendors, service providers, contract manufacturing organizations (CMO) and analytical laboratories; non-conformance reporting, review and approval; surveillance of manufacturing campaigns, review of batch documentation and data, batch release; review and approval of all documentation and data for the Chemistry, Manufacturing & Control (CMC) section of the NDA; preparation of the company and CMOs for Pre-Approval Inspection (PAI) by the FDA.
Submission of the CMC section of the NDA was achieved in 2003. The FDA conducted PAIs at one CMO and at INEX in 2004, which resulted in no adverse observations related to INEX or the product. Key to this success story was the team that Tony brought together and led for the duration of the project, providing great attention to detail, dedication to the project and determination to succeed.