The phrase ‘quality is quality’ often sparks debate amongst quality assurance professionals.
We’ve been working with some incredibly exciting cell and gene therapy organizations over the last few months, to help them largely with quality assurance leadership roles and consultant positions. Finding the right quality assurance talent is a challenge that often sparks discussions, particularly when it comes to the question of hiring candidates without direct experience in Advanced Therapy Medicinal Products (ATMPs). The notion of whether “quality is quality” in the context of those individuals who may not have worked directly in the AMTP space, is one that I took to my LinkedIn network to determine the general consensus.
In a field that lacks the decades of data and experience found in traditional pharmaceuticals and biologics, the search for strong and experienced leaders takes on a unique dimension. This article aims to discuss the complexities of talent in CGT and explore different perspectives on whether to hold firm on seeking direct CGT experience or to embrace the “quality is quality” philosophy.
The Context:
In conversations regarding leadership roles within cell and gene therapy biotech companies, the topic of experience with ATMPs often surfaces. Unlike traditional pharmaceuticals, where established practices have accumulated over a century, CGT is a relatively nascent field. This presents a challenge when seeking leaders and professionals who can navigate the complexities of bringing these cutting-edge therapies to fruition.
The Dilemma:
The assertion that “quality is quality” is often heard from candidates without direct ATMP experience. This becomes a focal point when considering positions in companies that specialize in cell and gene therapy. Should these companies continue to prioritize individuals with direct CGT experience, or is there a compromise to be had and embrace candidates with relevant quality expertise? Afterall – quality is quality – isn’t it?
On the one hand, CGT poses unique challenges. Cell therapy is a complex manufacturing process, and there is a considerable degree of learning to be done. Working in the grey zone, with regulations that may not be quite as clear as traditional small molecule and biologics, can be difficult to navigate for those new to the field. Let’s take, autologous cell therapy as an example. Autologous cell therapy refers to the use of a patient’s own cells to treat a specific medical condition. This represents an extremely complex end-to-end process. Everything must go perfectly. Cells are being transported between countries and geographies, and understanding this and the complexity of the supply chain is an important factor. Patients are often in a position where they have no other options, and therefore having a quality team and leadership that is well trained, experienced and aware of the processes and procedures in place, could be the difference between life and death in certain cases.
On the other hand, for the cell & gene therapy market to continue its momentum gained over the last decade, the gap in talent must be addressed quickly. In our last blog, we explored methods companies can take to navigate the skills gap within CGT. If companies don’t have robust quality processes in place, developed by experienced quality professionals, there lies the risk that the large pipeline of ATMP’s in clinical development don’t reach patients quickly enough. Should organizations be compromising on hiring people without direct CGT experience rather than leaving too many gaps in processes and thereby potentially slowing down progress?
In reality, the answer is probably a bit of both. Companies may need to compromise in certain cases. It could depend on the significance of the position they are hiring for. For example, a cell therapy biotech heading towards commercialisation may not compromise when hiring a Head of Quality, as opposed to more junior QA associates. However, one thing that will remain consistent is that, if there is a compromise, ensuring that the company has robust quality processes and strong culture in place is critical. Several of my network tell me if the ‘culture’ of the organisation is strong and senior leadership display a ‘quality’ mindset and attitude, this will often stem through the rest of the organisation. Thereby making that ‘compromise’ more likely to pay-off in a positive manner. As cell and gene therapy organisation grow and more therapies are brought to market, the question of whether ‘quality is quality’ will continue to draw attention from both hiring managers and job seekers. Utilising the skills of consultants with strong CGT experience will continue to be a good option and may allow companies to upskill the workforce, whilst providing specific expertise where there are potential gaps in processes or knowledge.
One thing that is clear is that the industry’s rapid evolution demands individuals who can navigate its intricacies. Striking a balance between the immediate need for experienced professionals and the cultivation of fresh talent will be crucial for the CGT market to bring their therapies to the patients who need them most.
Hemish Ilangaratne
Founder, Rx Group
