Quality Time Bomb or Are We Overstating the Case?

Quality Time Bomb or Are We Overstating the Case? After our recent survey we discuss further our findings.

At PiR Resourcing we have a strong focus in the mid to senior level recruiQuality Time Bomb or Are We Overstating the Case?tment of QA professionals on both an Interim and Permanent basis. Over the last 7-8 years we have noticed a number of trends occurring in the sector, namely a change in the UK Pharma Manufacturing market and a significant increase in the number of freelance QA consultants and QP’s. More recently the challenges within the UK QA market have become apparent. In particular a shortage of experienced QA professionals with strong leadership experience and a move away from QP’s being permanent employees,  opting  instead to release product on a freelance contract for services basis.

We were keen to validate our thoughts around these topics with the QA community; what they felt the challenges and potential solutions could be. A survey was commissioned in July 14 of both interim and permanent QA professionals, from manager level through to VP, to gain as broad and balanced an assessment of the current situation as possible.

If we look at the perceived decline in UK Pharma manufacturing, the response was very interesting. The general consensus was that there is an overall reduction in UK manufacturing capability with 87% of respondents agreeing with this statement.  This was balanced with a number of comments that thought that although there had been a reduction in the large supersites there had been a rise to compensate in the Contract Manufacturing Organisations.

In some cases this has been a re-distribution from multinationals to UK based companies now performing as CRO’s

In support of this, what I have found is growth in the CMO market and increased recruitment by the companies that outsource their manufacturing, requiring teams who are UK based to manage these globally based CMOs. Equally, we are seeing new manufacturing facilities being built in advanced therapy development and manufacture. Excellent examples include the Cell Therapy Catapult which was recently awarded £55M to build an ATMP site  to ensure the UK’s market leader position in the commercialisation of these ground breaking products and ReNeuron’s new facility in Cardiff. So whilst we have seen a move East of the less complex pharmaceutical manufacturing process, the more complicated biologics and advanced therapies have been prospering in the UK.

It was felt by survey respondents that whilst these changes in the manufacturing landscape may lead to increased QP demands for imported products, they may not directly impact on the amount of QA work available. It is likely there will always be a need for UK manufacturing in the highly complex  manufacturing processes where it is the technical capability to manufacture rather than the price point which determines location. We also asked about the key challenges that impact on quality teams being able to deliver against organisational objectives. Key concerns were lack of experienced QA leadership, with the relevant technical skills, the availability of QP’s in general and the retirement of experienced leaders and QP’s resulting in corporate memory loss. Another issue we hear as recruiters amongst trainee QP’s is the struggle to gain the experience of diverse products to achieve full QP status.  Freelancing is one way around this as no doubt the closure of the old supersites with multiple dosage forms  has compounded this issue.

Comments were made by a number of respondents that the QP who is doing batch release does not have a defined career path and can be viewed as a “hurdle” to batch release. This can result in their relationship with the employer becoming somewhat transactional, particular when they work alongside freelance QP’s with its perceived lifestyle and financial benefits. This in part has contributed to the high proportion of freelance QP’s we see today which in turn has led to a significant increase in the day rates charged by freelance QP’s. The knock on effect of this is more permanent QP’s joining the freelancers for the increased earning potential, flexible lifestyle and diversity of work.

I believe the lack of leadership talent in QA and the rise of the Interim QP are intrinsically linked. Historically we found the QP would batch release for a period of time and then either move into a leadership role or undertake QP training as a QA Manager and then move up through the QA ranks. Now some QP’s are going freelance as soon as they gain registration and are not developing leadership skills.. This in turn will mean a challenge for these Interim QP’s in years to come if they decide to return to a permanent career as they will lack the management experience compared to their permanent peers.

So what is the solution? Companies should consider offering a defined career path for the QP’s with financial incentives to offset the earning potential of freelancing. As a recruiter I will have greater success persuading a freelance QP to return to a permanent role if there is a clear career path in a successful organisation developing interesting products. This in turn should see the pipeline of leadership talent increase and a level of stability return to the UK QA market.

At PiR Resourcing we would be interested to hear your thoughts and comment on the challenges you face as a QA professional and what might been done to improve things both from a leadership and QP perspective.

Mark Johnson Client Services Director Executive Search

Mark is a respected executive search and recruitment professional with a background in science and the Pharmaceutical industry. A graduate in Applied Biology Mark has industrial experience of biologics manufacturing development at MedImmune and Novartis, where he worked in development, manufacturing and quality for vaccine products that ultimately made the transition to full global release. While Mark focuses on senior level positions in Manufacturing/Supply Chain development, Regulatory, Quality, and Medical he is able to add real value to executive search assignments across a variety of disciplines.

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