A Qualified Person (QP) is legally responsible for certifying batches of medicinal products before they are released for use in clinical trials or available on the market, and ultimately assuring the quality of medicines. But a QP doesn’t just need expertise in manufacturing practice, they also need to understand the factors that can affect the safety of medicines and supply chains. That’s why it’s important QPs are rigorously trained and given an in-depth understanding of pharmaceutical manufacture.
Before Brexit, the UK was able to hire QPs from any location within the EU to perform batch release certification, however, post-Brexit, we must only hire QPs based in the UK – resulting in a lack of supply and a rise in day-rates and salaries. I spoke to the Vice President of Quality at a global biotechnology organisation and asked her about the challenges of hiring QPs within the UK, and how we might overcome this issue in the future.
Thank you for agreeing to be interviewed regarding the recruitment trends for QPs in the UK. Would you mind giving me a brief introduction to your company and role to start?
I am the Vice President of Quality at a global biotechnology organisation. We have gone through a period of mergers and acquisitions over the last few years. We are best known for supplying emergency, critical care products for hospitals globally. I started my career within biologics in the mid-1990s and then started my QP training officially in 1998. I was keen to get this QP status as soon as possible, however, what a lot of people don’t realise is that you must have 2 years of experience of working at a site with a manufacturing license prior to making an application to become a QP. Our site didn’t obtain a license until the year after I started QP training. So, once I had these 2 years under my belt, I was then keen to start my application. However, a colleague I was working with who was also going through their QP training at the same time, wasn’t initially successful, so this set my confidence back slightly. I then ended up slow tracking it somewhat and ended up qualifying as a UK QP in 2004.
It is great that you now have your own team of QPs in your leadership! Do you have a preference when it comes to hiring permanent or contract QPs?
I typically run between cycles of having lots of QPs and then suddenly feeling a bit vulnerable due to normal staff turnover. Based on previous experience we have found it challenging to recruit QPs and I hold the assumption that it can be a challenging and lengthy process to hire an external permanent QP in our very rural location. So typically, we rely on a mixture of sponsoring our own employees through QP training and a heavy reliance on contractors. Some of these contractor QPs are named on the company’s manufacturing licenses, but only typically do 11-12 days of work for us per year. They are great for sudden urgent needs, but I cannot rely on them for any heavy lifting project work, which is a shame as they can be very expensive.
How do you feel about the day rates that contract QPs can command?
A few years ago, the QP rates tended to range quite significantly. However, these days it seems that the vast majority of QPs in the market desire a day rate close to or within 4 figures. It is understandable, as sterile biologics as products require a specialised skill set and the pool of appropriately experienced QPs is limited. A constant factor from my training in 1998 to the present day is that many QPs are very keen to go straight into the contract market after qualifying, whereas fewer want to go down the management route and have more accountability for a team and product range.
How has QP availability change since Brexit?
I do wonder if UK QPs are now somewhat devalued in the European QP market. Prior to Brexit, I used to be able to release batches of products from the UK to all EU member states. Now this duty must be performed by a QP within the EU. UK QPs are very lucky that the UK has such a thriving biotech and pharmaceutical industry to keep us working, however we must acknowledge that the UK industry is becoming more limited. We lost one QP from our organisation who was from Germany immediately post-Brexit, as they were keen to make sure they could continue to operate across the EU. We are now quite reliant on the expensive contract UK QP route for hiring.
In your opinion what can the three Royal Societies do to increase the numbers of new permanent and contract QPs?
You can fast-track QP training across 1 year or slow-track QP training across several years. On completion of the course and if you have the required industry experience, you must complete a detailed application form and submit it for review. This form is then reviewed by assessors at the three Royal Societies and if deemed acceptable, a date for a verbal examination (viva) is given to the candidate. Prior to COVID-19, the vivas were conducted by a panel of assessors on location at one of the Royal Society HQs in London. These days, during the COVID crisis, vivas are conducted remotely via a video call.
The time from submission of the application to taking the viva is over 6 months, which adds significantly to the time taken to qualify – particularly if the candidate has fast-tracked through the training course. Speeding up the review process for the applications and creating more viva dates would speed up the qualification process and generate more QPs for the industry.
My understanding is that the QP assessors at the Royal Societies are paid expenses only and certainly pre-COVID there would be a disincentive for potential assessors outside of London/home counties to get involved in this. For example, I would be potentially interested in getting involved as an assessor in the future, as it would feel like I am giving back, however travelling up and down to London and taking time off work simply isn’t viable for no reward. If assessors were given a financial incentive, then this would help with the recruitment of assessors, meaning there would be more vivas being hosted and ultimately more QPs being passed in a timely manner.
How are you planning to retain the QPs you do have in the business?
Our HR department uses industry surveys and we keep in touch with industry professionals regarding what our competitors are paying their QPs and we are doing our best to action this. We also try to keep their role responsibilities as varied and exciting as possible.
If you are an industry professional within the Quality market looking for insights on salary or day rate benchmarking, please do reach out to me via hevans@inveniagroup.com
