“I like to encourage people with the fact that we are developing products that will ultimately save lives, but to achieve that, quality must be at the core of everything we do.”
What’s your name and job title?
Nicola Emmett – Quality Assurance and Regulatory Affairs Manager
How long have you been at LightOx?
Four years.
Can you share a bit about your previous experience in the health and life sciences industry?
I have a strong scientific background as a medical microbiologist and gained a BSc (Hons) in Biomedical Science before going on to complete a Masters in Medical Microbiology.
I started my career as a Biomedical Scientist (Microbiology) in the NHS and went on to specialise in mycology and andrology. I then left the NHS to become Head of Microbiology for a private pathology lab. This developed further into the quality and regulatory field as I led the lab to gain CPA (clinical pathology accreditation; ISO 15189). I then went on to work in various positions within the pharmaceuticals and medical devices industry gaining multiple knowledge in GLP, GMP, ISO 9001, ISO 13485, corporate and legal compliance.
What are your particular areas of interest and expertise?
My main areas of interest and expertise are in the quality and regulatory field particularly within pharma and medical devices including; GLP, GMP, ISO 9001, ISO 13485 and also legal compliance within health & safety and data protection.
I also have a particular interest in training and encouraging staff in the benefits of a good QMS (Quality Management System). I’m a firm believer that developing a QMS should be tailored to company’s specific requirements, rather than being wedged into a company. It should be holistic and aligned with the businesses’ scope/mission and organisational values.
What role do you play in the development of LightOx’s new therapies for oral cancer and wound care or in supporting the LightOx business?
My ultimate role is to lead LightOx’s products through regulatory requirements into clinical trials and then to market. This involves working with the LightOx team to implement quality by design, working with regulators, CMOs and CROs. It also involves developing clinical plans, proposing and managing regulatory pathways, developing/implementing and managing our QMS.
As a small company we all work together to achieve our goals, taking on additional tasks where needed, so I also manage health & safety, facilities management and data protection. We certainly keep ourselves busy! We are a great team and work really well together.
What do you like the most, or find the most interesting about your role?
Whenever you work in quality or regulatory you not only work closely with people in your department, but you work with everyone across the business too including external suppliers. I love working with such diverse groups from scientists to engineers, lawyers and corporate. I also really enjoy helping people understand how a good QMS can be of benefit and why regulatory compliance is so important to produce a quality product.
What does a typical working day at LightOx look like for you?
There’s no such thing as a typical day as it very much depends on which location I’m at and who I’m working with on that day. Quality is an area that has to be fairly reactive in approach, particularly if there’s a non-conformance or a health & safety incident.
When I’m working from home those are the days that I tend to develop regulatory plans further and work on the management of the QMS. Regulations continually change and each market often has different requirements so there’s a lot of reading and reviewing standards/guidance and updating LightOx’s processes to reflect that.
With regards to managing the QMS, Quality if implemented correctly should never be a burden and is something that never stops developing as there is always continuous improvement to be had.
What are your hopes or ambitions for the projects you’re working on?
I always like to encourage people with the reminder that we are ultimately developing products which will go on to save lives, and in order to do this to our very best we must put quality at the core of our product lifecycle (quality by design).
My hope would be that our early stage oral cancer drug would go on to save thousands of lives and greatly improve the quality of life for cancer survivors. Our ambition would then be to follow this to market with our wound care product again significantly improving patients’ quality of life and helping the NHS with the burden of wound care and antimicrobial resistance.
When you are not at work how do you like to unwind?
At home we’re currently raising a guide dog in training, so a lot of our free time is spent around her. She is such an intelligent and joyful puppy. For all the hard work it’s a really rewarding experience and we know she will make such a difference to her new owner’s quality of life. When I get some none puppy time I really enjoy mountain biking, though I’m probably a bit rusty at this now!
Who are the 4 guests dead or alive you would invite to your dinner party?
This is a really tough question. I would always go with family and friends first, it’s the limiting to four I would struggle with.
Other than family and friends I would love to learn from some strong female characters let’s say: Marie Curie, Margaret Thatcher; Elizabeth I and Nicki Minaj!
Finally, in another life what would have been your dream job?
I’m a really logical and analytical person, so my dream job would have to involve some type of investigational work/problem solving so maybe MI5 or a corporate fixer?!? Now that would be interesting!
