This post originally appeared on LinkedIn.
January 31, 2017
In my last post, I looked at the technical skills required to succeed as a Quality Assurance Recruiter
in a market that’s veremy technical and which requires in-depth subject matter expertise and relationship building savvy. My thoughts this week turn to talent scarcity in the ‘new normal’ environment of increasingly stringent regulation.
As product types become more complex, the increase in the levels of risk has led to increased regulatory surveillance of pharmaceuticals, the result of shoddy practices which, in the most extreme cases, have resulted in patient deaths. The regulatory agencies, led by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and its country affiliates, are on the case more than ever.
The knock-on effect is that while more employment opportunities
are being created for Quality Assurance experts, for example in Sterile Injectables, Biologics and Advanced Therapy Medicinal Products (ATMPs), the talent pool is much diminished. Many individuals previously focusing on lower risk products don’t have experience of higher risk environments, so there’s a real dearth of experienced talent in Good Manufacturing Practice compliance at these levels.
Lean model, robust quality
Those companies with the highest levels of GMP compliance usually run a leaner staffing model governed by robust quality assurance principles and a Quality System that is not over-complicated. The staff in these firms truly believe in quality and are financially compensated to reflect this level of professionalism and belief. You shouldn't build a quality team on the cheap. To have a great quality team, you need to ‘overhire’ within a lean Quality System model; in other words, make sure you have the right talent but don’t overdo the bureaucracy or the effectiveness of the Quality System will be greatly reduced. More staff does not necessarily mean better quality and less (overworked) staff than you need will be a real problem sooner rather than later; its a true balancing act.
The need for appropriately experienced talent is more important than ever given that the regulatory audits are far more thorough nowadays – e.g. teams of four FDA inspectors (Consumer Safety Officers) sent over a two-week period for one site – and the level of expertise they bring with them is more specialist than a few years ago. Very rarely will a company pass all the criteria. Yet while clamping down on regulatory laxity is to be commended, especially with patient safety in mind, it’s making it harder for organisations to keep up with regulatory demands.
Companies that cut corners (and costs) in the level of competence of their quality assurance talent will pay the price. Quality should not be perceived as a 'cost' but more as an integral part of the commercial process. The cost of product recalls or even country bans are far more expensive than a solid quality unit and will hit the bottom line egregiously. Global Heads of Quality must do all they can to attract and retain these professionals, continually reviewing the regulatory expertise they need.
It’s a challenge but ultimately you just cannot scrimp on quality. Those frequent cGMP Warning Letters will serve as timely reminders. It really is all about quality in the end. Without that you don’t have too much even if your product is spectacular.
As always; thanks for reading. I’d love to hear your thoughts so please post your comments below.