Transcript taken from 2022 PMWS by Executive Platforms
The talent crisis as it has been called is certainly not something that has gone away or frankly, I don’t think will go away. I’ve been doing this kind of work for a long time, and I think to some extent it tends to be undervalued and really looked at as a secondary place for people in an organization. The reality is that to do this job well, to do a quality job, a compliance job, supporting the operation, ensuring good product quality, ensuring regulatory compliance, helping companies with their commercial manufacturing, requires a large multiplicity of disciplines that people need to be highly skilled in.
None of these are in order of priority, but to start out is understanding of technical context of products. You have to have some sort of a technical background, or if you don’t, you have to have a lot of experience in a technical framework where you’ve learned through experience the technical principles of product manufacturing. Because at the end of the day, what we’re talking about is manufacturing of primarily therapeutics for our discussion. Therapeutic products that are going into consumers, customers, and patients…and they’re highly technical. There’s a lot of science, there’s a lot of engineering, there’s a lot of specificity and accuracy that is necessary, complex processes complex equipment. so this technical knowledge or technical framework or technical skills is critically important.
The next thing I would say is regulatory knowledge / regulatory science. We are operating in the life sciences sector, and around the world that is regulated sector. It’s a regulated industry vertical. In the US of course by the Food and Drug Administration, which has traditionally been one of the premier organizations. But, around the world, the international regulatory bodies have come to equal, in some cases, exceed FDA regulatory science. They’ve learned a lot from the FDA over the years, but they’ve really advanced around the world. Whether it’s China, or Japan, or Europe, or Brazil, and other secondary countries or countries that may not get as much notoriety, the regulatory frameworks are complicated. It’s also complicated in the fact that companies often operate in multiple jurisdictions. There’s a necessity to be able to understand where their primary markets are, understand those requirement sets, and then understand how to apply those in different levels of importance based on the market. So, regulatory science is critically important.
We’ve been in the pharmaceutical industry in a regulatory environment going back to at least 1978 when the when a major rewrite of the pharmaceutical drug GMPS were put in place. And over the last 30 to 40 years there’s been an explosion of regulatory requirements, and explosion of regulatory expectations. Now, a lot of that has been great for industry because it helps them understand how to approach the manufacturer in a predictable, consistent way. But, on the other hand, for talent in this space, there’s a lot to learn and the learnings are not just what’s today, but how did this evolve over the years? Because that helps form the expectations, and that that evolution of regulatory science informs how regulators apply different concepts. I would say regulatory science, in addition to the technical sciences, it’s critically important.
The third area in modern pharmaceutical, medical device, biopharmaceutical manufacturing is digital skills. Digital skills are so critically important now. This overlaps into other discussion areas. The quantity of data that is able to be generated now, and often is generated by companies, is extraordinary. The tools that facilitate the operational quality and compliance frameworks, they’re all digital, right? Everybody is using computers from morning till evening and nowhere is that more true than in this regulated sector and in regulated manufacturing. This this digital knowledge goes beyond just using a mouse and a browser, right? You really need to understand some basic principles of how to you know how computers work data models, data structures… because those data structures and how the information is contained, how that flows, how it moves from place to place, is important to inform the decisions that will be that will be necessary to kind of think about and explain going forward in the future. Digital skills are critically important and are something that if people don’t have them, or don’t have them in a manner that’s adequate, that they need to get.
Another skill I think is critically important is writing. Now, going from digital skills, you may say, “Well, why writing?” Well, the challenge with the future is that given the fact that everything is digital, that people assume that that’s enough. I’ve got data, the data will the data will tell the story. The data doesn’t help story and it doesn’t tell a story to the regulators. And, it doesn’t tell the story necessarily to the internal stakeholders and internal collaborators relative to a multiplicity of problems or situations that occur. The ability to look at the information that’s in front of you, and be able to right cogent statements of explanation, context, rationale, conclusions is critically important. It’s also critically important given the fact that now with the post-COVID model, there is more of a of an ability for the FDA to look at things in a virtual environment without the what I’ll call the “handholding support” of quality personnel that typically help an inspection context. Where we’re in the past information was explained verbally, and you talked through to regulators, now a lot of that is either contained digitally, or it’s contained in documents. And, hopefully it’s contained in documents, because those documents tell your story.
So there are certainly other skills, but I think that those are at least four areas that are important to the modern quality professional and those are key skills that we’re going to need going forward in the next 5 to 10 years.
