am responsible for the implementation of the requirements of the forthcoming
European Union Medical Devices Regulation within the Quality and Regulatory
I joined the company I currently work for in 2000 and have been in this role, with increasing responsibilities, since then.
I studied Pharmacy at the University of Bath and graduated with a Bachelor of Pharmacy degree in 1979. I completed my preregistration training in hospital pharmacy and registered as a member of the Pharmaceutical Society of Great Britain in 1980 (now the Royal Pharmaceutical Society).
I returned to the University of Bath to undertake research for a Ph.D. in pharmaceutical microbiology.
On graduating, I joined the Scientific and Technical Branch of the Department of Health, initially working on sterilization but having opportunities to be involved in GMP/Quality Management and a wide range of other areas. This went through several reorganisations and I had positions of increasing responsibility, ending up as the Head of the Device Technology and Safety unit. I became a Fellow of the Royal Pharmaceutical Society in 2004.
There is no such thing as a typical day – the main feature of my work is the variety – on any particular day, I could be almost anywhere in the world, at a manufacturing facility, meeting with regulators or industry associations, developing international standards or presenting at a conference.
started with responsibility for compliance with regulatory requirements for
quality in Europe, Middle East and Africa and have since taken on wider
geographic responsibilities and taken on specific projects. Then I established
a new Compliance function with responsibility for the company’s medical devices
companies worldwide before taking a newly created position as Head of Quality
for our medical devices sales and marketing companies around the world.
I wanted to continue being involved in activities with a technical focus but in a broader range – I had the opportunity to be involved with pharmaceuticals, medical devices, diagnostics and consumer products throughout their lifecycles.
work with a variety of different teams in the Quality and Compliance function
as well as in cross-functional teams.
I am not based in a single location and travel a lot, it is difficult to say
where I work! When our global teams get together there is always a social as well
as a work dimension.
I have been involved for many years in developing international standards for validation and routine control of sterilization – we have just completed a major revision of the standards for major sterilization processes and, for the first time, published a consistent and coherent (I think) set of standards. I also have worked extensively on international standards for quality management systems, including the revision of ISO 9001 and the revision of the medical devices quality management system standard ISO 13485.
I was involved in co-leading a team looking at the relationships with external manufacturing partners, which included a review of the way that relationships were managed in countries all around the world. We have now rolled out a set of standards and processes that are being implemented at the moment.
I have also had the opportunity to establish new groups within the Quality function from the ground up.
think that the most important things are to have a positive attitude, be
flexible and be willing to learn.
are a range of possibilities and I don’t want to restrict myself by having too
specific a plan.
Credibility and flexibility. Also, to be able to see how
the detail fits into the big picture and to get alignment across a variety of
functions within the organization.
There are a wide range of opportunities – don’t let yourself get put into one pigeon hole.
If I made a mistake the whole batch of tablets would have to be scrapped, so that’s a million pounds down the drain