AssureBio’s Post

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I mean, especially as a contractor, you've walked into different organizations potentially who may be in a bit of trouble. And so you have to go in there and obviously help them and consult them. So managing upwards. That communication style, how very different is that compared to leading a team? Yeah, I think. I think when you manage upwards and I'm the first one to say that that I'm. When it comes to senior management, I guess I'm less tolerant as a QP or a contractor than than it perhaps should be. I've I've tried to evaluate at times why that would be. I I tend to. I've I've had to try and work on. Different ways in in in which to approach certain scenarios because my by default setting is to listen. Understand and then if I think the person is is not genuine or doesn't have the best interest at heart, then I tend to be. Um, they tend to know that fairly quickly and that's something that I need to need to think about the. The thing is, though, is, is that one of the first jobs is to get them to understand why it's important. And that again, has been on LinkedIn recently quite a bit. And I think that's a very, very important and valuable discussion to get into. Most senior managers, they they're very senior people. They don't want detail. And as a scientist, that's a challenge for us because we like detail, we like to give detail. So if you're a QP and you're communicating with senior management, you have to cut it down. You have to, you have to get the salient points together and you have to communicate in bite sized chunks that that is easy to understand. They don't have time. They're they're not just managing quality, they're managing a vast organization in some cases. And what they need is a way forward. Not for any, you know, another problem erected for them to think through. And I guess the that's The thing is that is that you should go with the solution, not the problem. And and that makes the gives the senior management a little bit of an easier time when it comes to deciding what to do. I guess the the other side of dealing with senior management is they are the ones that make the decisions and in in very rare occasions. You know that they're going to make the decision that's not good for the organisation and that's when. You have to be assertive, um, and you have to be very clear about what needs to be done. And to any young people out there who are who are wanting to be a QP, this is one of the the hard parts of being a QP. Sometimes you have to deliver bad news or bad news from a commercial perspective and you have to learn. Different ways in which to do that, but at the same time be assertive to make sure that the point gets across properly. And be prepared for the the the intense discussion that goes with it. I am. It's, it's part of the job in some circumstances. So yeah, that that's important. Yeah, I suppose that brings it back to the point where you mentioned earlier in terms of no one really teaches you how to communicate when you're going through the training to become a QP. However, it's a huge part of that job. Yeah, it's some, it's something. It's something that I've considered. Not really had the time to look at yet. Hopefully at some stage you will, but communication should be part of I think, the curriculum. And, and managing in those scenarios, as, as I said, very early in the conversation, you suddenly go from being Joe Bloggs who is sauntering along, doing your job to somebody who's in the spotlight. And people look straight to you to make decisions, proper decisions, the right decision. And they expect you to know the answers to everything. Don't be tempted to try and know the answer to everything. So I suppose in retrospect then what, what guidance would you offer to a younger Kev and starting out his journey in in quality assurance and in particular that's going for the QP training? Wow. Crikey. I think, I think that that's a good question. What, what would you? What would you say to yourself? Well. I think I think I've covered most of it already in the in in the discussion. Don't pretend you know the answer. It's OK to not know what the answer is. And I guess that's the same in management as well. You know, you, you'll feel in the spotlight, you'll feel like everybody's watching you. You'll feel like everybody's judging you. All, all of these things. Most of it will be in your head. Most of it will be in your head and not and not actually be the reality. So you need to talk to people. You need to get out there and, and do the communication. You of course have got to put the hard yards in. You've got, you've got to learn there. There is a commitment. For for new people to come through and it's a bigger commitment than I went through because the legislation is much bigger. The complexity, the complexity is there. And the changes that are going on are quite staggering at times. I think as far as possible with procedures and processes, people have to simplify what and that comes from talking to the people that you're working with, I would say. You know, be less important, be more humble when it comes to learning stuff and being with people. I probably would have said to myself, uh, you need to study harder at university instead of having a great time. It was the 80s of course, and the music was fabulous. And you know, there were lots of other distractions in those days, but that would be something that that you could probably probably say to yourself. You get something out of it when you put something into it. Over the past, I don't know, 15 years or so, when I've done various lecturing and on various subjects with students and what have you, I'm always asked what what do I need to do to be a QP? And it's hard work, but that's what you need. You need hard work, dedication and the. The thing that you shouldn't go into it for, although the rewards can be good, is not just for the money, because it's not just for the money. It's for the patient, Yeah, at the end of the day, and you need to keep that in mind. Yeah, that's supposed to the last bit of information or last bit of information I give my former self is, is, yeah, do it, Do it. Cause it's been fabulous, Absolutely Fabulous. I can, I can look back on my career. Yes, there's been ups and downs and there are people that that have come across who who I haven't gone on with. But overall I'm I'm really satisfied and pleased and proud of where I've got to. I'm. I suppose it's worth saying as well that that. How I feel is built built on by the knowledge and and care of others to get me to where I am now. Brilliant cap. Yeah, now this sounds like you're the hard work has paid off for yourself and it's been extremely rewarding over the years. And my final question. Sorry there. So our final question Kev is you, you touched upon it a few times is in terms of I suppose the the fast changing legislations, regulations within the industry and there's there's a lot to keep on top of. So how do you see the role of a QP evolving in the coming years? Them I think to start with it. The QP as it stands at the moment, So if you look at the study guide at the moment for a QP, it's broad, it has to be once you've. Once you pass the Viber you you're expected to slot into any scenario to be able to function as a QB. Umm. But things are changing. The the the manufacturing base in this country has decreased. So if Q's want to get experience in different parts of manufacturing, and it's an absolute must that you must get that, then people are going to have to work harder to get through that. And to get enough experience to be able to to manage in those situations. Um, obviously medicines are changing. We're, we're moving to preventative medicines and the biologics and all of the innovations that are coming through which require different, different knowledge and disciplines. Colleague of mine is was at the very forefront of that some years ago. It is now massively in demand because there aren't so many people around with with her knowledge. And I think the the scientific disciplines that people will need will probably change somewhat too. Q's may become more specialised. You know the currently QP is expected to be able to move from one place to another, to be able to deal with different different scenarios that might change and there may be a need to to have specific QP types for certain things. Over you talked about legislation or you know the the orange guide is. Is a recipe for back pain problems. If you carry it around these days it's in a much bigger tone than it ever used to be. I think, I think also the good thing from a QP's perspective is the inspectorate are starting to look to the most senior management in an organization looking at the quality culture and how developed the quality culture is and I think that's long overdue. You know, the QP is expected to be all things to all people, but the one thing that it's it's very difficult to do from the Q's role is is. Completely influenced the the company in in what needs to be done from a quality perspective. It has to come from the people at the top. Um. I think the. You know the. The the thing about being more specialized. I I don't think that will come anytime soon. One of the difficulties that we face of course is, is that the QP getting new QPS into the industry is. Still a challenge. The pass rate currently is around 50% in Viva. I may make a couple of points about that that's. So it's worth if if people are going through that process, it will help. I think people have to remember that, yes, you have to know the legislation and you know, that's the challenge goes as I mentioned earlier. Yes, you have to know about each different discipline within the study guide, but the biggest one of all is that the fact that you may know all of that stuff, you've still got to be able to coherently present it when you're given a scenario to deal with. It's no good if you're the most knowledgeable person in the world, but then cannot bring that knowledge to bear to manage and control the situation. Which may be serious for the patient. So from the perspective of of all of those three things, you have to remember that if you have the all the knowledge in the world and you know all the legislation in the world, it will not work if you cannot pull it together into a coherent strategy to manage a scenario in a situation. If you're unable to do all of those three things or one of those three things, it is difficult for you to go through the fiber process. And of course, that's what you'll need to do in real, real life. So the that going through those those three steps is very important and and key to get in success.