Ask Me Anything: Careers in Quality
In this week’s Ask Me Anything series, Chris Frew, CEO of BioBuzz Networks, spoke with Stephen Tyrpak, Vice President of Operations, US & Canada, Local Equity Partner with PQE Group, to discuss quality, one of the most in-demand careers in Biopharma.
March 27, 2024
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In the dynamic landscape of biopharmaceuticals, one aspect stands as an unwavering pillar: quality. From research and development to manufacturing and distribution, maintaining the highest standards of quality is paramount. It’s not just about meeting regulatory requirements; it’s about safeguarding health, ensuring efficacy, and fostering innovation.
Quality assurance and control processes are the backbone of the biopharma industry, ensuring that every step of the drug development and manufacturing journey adheres to rigorous standards. At its core, quality in biopharma is about patient safety. Each pharmaceutical product that reaches the market must be reliable, consistent, and free from contaminants. This assurance not only protects patients but also builds trust in the healthcare system and the industry as a whole.
In today’s global marketplace, where consumers demand transparency and accountability, quality serves as a competitive advantage. Companies that prioritize quality not only meet regulatory requirements but also earn the trust and loyalty of healthcare providers, regulators, and patients.
Learn more about quality in biopharma from Stephen Tyrpak and Chris Frew in this week’s recording and transcript:
Chris Frew [00:00:02]:
Good afternoon everybody. Chris Frew here with BioBuzz, excited to do another AMA. Today we’re talking about careers in quality with Stephen Tyrpak, who is VP of operations for the US and Canada with PQE Group. Stephen, welcome.
Stephen Tyrpak [00:00:18]:
Hi Chris, thanks for having me.
Chris Frew [00:00:20]:
My pleasure. Excited to talk to you today. Quality, quality careers are one of the most in-demand career fields in biopharma and med device. I have a feeling you’re not.
Stephen Tyrpak [00:00:33]:
I am. It’s one of those things where no one wants quality, but everybody needs quality. So it’s a good time, I think. Yeah, for sure.
Chris Frew [00:00:41]:
That’s great. Well, I always like to start off with a little bit more about you. So again, from what I’ve heard talking to your colleagues is that you are the medical device guru at PQE. That’s one thing we’ve heard also that good at helping startups get funding. It sounds like you work with a lot of startups in the space and that you’re the quality culture guy. So I’m excited to unpack some of that stuff with you here today on our conversation. And before we jump in, let me just give a quick plug for BioBuzz. Most people are joining, probably know us by now.
Chris Frew [00:01:19]:
If you are just joining, BioBuzz is an online platform to help better connect life science professionals with careers in biopharma. So we appreciate you being here today. Please make sure you also sign up for our newsletter to stay up to date on future events with other leaders like Stephen on the call. So yeah, let’s jump into it. Stephen, do you mind starting things off.
Stephen Tyrpak [00:01:41]:
For us with the introduction?
Chris Frew [00:01:42]:
More about what you do?
Stephen Tyrpak [00:01:44]:
Absolutely. So I actually started my career in pharmaceuticals. So I was working in clinical research in pharma and I basically worked in every field besides quality. So I started in clinical research, I started in nonclinical study designs, and core manufacturing, and everything was leading me to quality. I think everything eventually ties into quality. It’s why we do what we do and it’s how the standards get to what we expect them to be, but also what agencies expect them to be. So I’ve held different positions in quality and regulatory, focused on clinical quality, focused in manufacturing of medical devices and pharmaceuticals. And I worked in the industry for a long time, a lot, focusing on big pharma, big medical device.
Stephen Tyrpak [00:02:26]:
And then I segued into supporting startups. I noticed that a lot of them don’t know what they don’t know. They don’t have the tools, they don’t understand what quality is and data integrity and all these things that we know are important, but they don’t have the tools to get there. So supported them in developing programs, to be compliant, but also supported some fundraising to help them grow and really get to the next phase in their careers. Also support a lot of institutions. So I’m supporting a lot of universities here in the US building quality programs. So a lot of them, they have these great ideas of these professors and they want to understand how do we commercialize this. So I’ve been able to partner with a lot of universities here in the US to build out GLP facilities, GCP facilities, 21 CFR part four, which is that computer system quality aspect.
Stephen Tyrpak [00:03:16]:
So I’ve really been able and fortunate enough to work with people around the globe to build programs, optimize programs and really facilitate good quality. Was recently just in India at their PDA annual conference, co-sponsored by FDA. Speaking on quality culture, speaking on combination product quality, speaking on manual, visual inspection quality. All things that regulations say what they’re supposed to be, but it’s our job as quality folks to interpret it, to build programs, to optimize programs, to eventually get it through. So yeah, quality is my life, I think, good or bad, and I’m glad to be here. What else did I miss? What else can I go for that’s good?
Chris Frew [00:03:58]:
Well that’s great. I mean you are clearly the right person for this conversation today. Maybe take a step back and tell me a little bit higher the level. Tell me about PQE group.
Stephen Tyrpak [00:04:08]:
Absolutely. So, PQE group, we are been around for 25 years, originating out of Florence, Italy. Our CEO Jilda started this company as a passion project and now we are more than 2000 consultants, strong all over the globe, everywhere from Japan to us. We have 40-plus offices now and we really do support the full product lifecycle, whether it be quality, regulatory, computer system validation, technical qualification. And we have a very unique perspective on consulting because we’re that European based. We have consultants who work full-time for us. We are a team of strongly experienced but also flexible consultants that really try to fit to our customers needs. So I’ve been very fortunate to be with PQE for two years now and really been able to see it grow, even the last two years.
Stephen Tyrpak [00:04:57]:
So it’s been a great opportunity for me and I guess if any PQE people are out there. Thank you.
Chris Frew [00:05:04]:
That’s amazing. A passion project that becomes thousands of people around the.
Stephen Tyrpak [00:05:10]:
And she, our CEO is here in Buffalo and I don’t know how she does it. I don’t think she sleeps. It’s amazing.
Chris Frew [00:05:17]:
That’s great. We’re here today to talk about quality careers. And something that, as you were talking, that really I thought of is the quality field is. There’s a lot that is baked into that, right? So maybe as a starting question, could you help segment for audience? Maybe let’s break down the quality field into what are the segments or the compartments that you typically will break that down into?
Stephen Tyrpak [00:05:48]:
And there’s different ways to look at it. And I think it’s something where when you look at quality as itself, there’s always just like any career, there’s tiers. So you have the technician. So people might have heard things like quality engineer, quality control engineer. Those are people who typically get specifications. They understand what the spec is and they’re on the field actually checking the quality of the product. So, medical device, you might be checking specifications, you might be doing internal audits for pharmaceuticals, you’re doing bats and your disability. People are hands on.
Stephen Tyrpak [00:06:25]:
A lot of people think quality is all just ring Sops, drafting Sops. There is a hands-on feature going level up. You have that more quality manager, quality supervisor role that their job is main quality system. So that’s more the call quality strategy. How do you take the regulation and ingrain it in your institution? A little bit higher than that. You have your C-suite quality. Those are people like chief quality officers. Those are people who, their job is to not just make sure that you’re being compliant to your quality system, but ultimately their responsibility is, are we bringing safe and effective products to the end user, which is patients? And at the end of the day, every field, no matter which level you’re at, your job is to bring safe and effective products to the end user.
Stephen Tyrpak [00:07:16]:
But ultimately it relies to that top part. So that’s looking at the manufacturing side. When you look at things like clinical, those are quality entities who are there to make sure that we are providing safe and quality treatments at a research level. There’s a higher caliber of control in that area. People who love research, people who love the idea of supporting new and novel products going to market, but they want to focus more on that quality side. I think it’s a good niche area to fall in because you’re still involved in the clinical research, but you’re not necessarily in the, or putting a knee replacement in, or doing patient follow up. So it’s a unique area there. And then there’s also business quality, which I don’t think we talk about too much.
Stephen Tyrpak [00:08:04]:
And business quality are typically people who are there built into the organization, who look at the systematic approach of the organization are our procedures quality for our employees are our quality. So there’s different to look at, but I think that’s typically.
Chris Frew [00:08:24]:
Yeah, that’s really interesting. You said something earlier, everything begins and ends with quality, and that’s a good full circle to see how really touches across the organization. So you talked about manufacturing quality, you talked about clinical quality and business quality. Quality is something organizations have to think about when they think of their data and their systems as well. Right. So for people that have a career in it or they have more of an information systems background, a lot of your clients sounds like there’s an element of quality in data as well.
Stephen Tyrpak [00:09:05]:
Correct. And I tie that into manufacturing selfishly. So your data and how you maintain your records is a huge portion of your organization. And when you look at life sciences and if you come from academia, you know that you are only as good as your data. And when you look at that data integrity quality aspect, there’s a computer system and those are people that their sole function is to ensure the integrity and the quality of data and electronic level and then. So paper-based quality. So, yeah, that’s a full process that expands throughout just manufacturing. Like you mentioned, it goes into all aspects and that is something that the guidance spells out very clearly.
Stephen Tyrpak [00:09:45]:
It’s not just making sure that there’s quality data, but it’s also the security of it, ensuring that people cannot alter it, people cannot manipulate it. And those are things that are so out of my comfort zone that the people who do it, I have the utmost respect for them because it does take a lot of knowledge in the software-based world to understand how do you manipulate code and how do you integrate code in all those different areas? So definitely an interesting field.
Chris Frew [00:10:14]:
Absolutely. Again, I’m going to keep plugging at you on different parts that I know quality just to get your feedback. Because we try to again, match job seekers with different professions, we see quality that impacts a lot. And I’m always curious how people can help to guide their career into areas of quality or areas another area. And this might fall into that first slide, we said, but where do compliance and auditing fit in?
Stephen Tyrpak [00:10:48]:
So I’m going to go to the first one. I’m only going to speak to my experience, so I can only speak to what I have found work with myself and some of our consultants here at PQE. Quality is a job that if you don’t have a passion for it, it’s not for you. Quality is really sometimes a thankless job. What I’ve always done is really identify what I want to do in my life. So if you want to make an impact and you want to see patients get a better life, then life science is definitely for you. But in terms of what do you see your day-to-day looking like, do you want to be hands-on? Do you want to be on the manufacturing floor? And we always say, boss each and make good quality associates, because you sometimes need to drive the processes and really be confident enough to raise your hand to say something’s wrong. But I never, I don’t always think it works for you to say, I want to be in quality and where do I fit? It’s more which part of the process do I want to ensure quality? Do I want to be on the computer system side? Do I want to be on the manufacturing side? Do I want to be on the systematic quality side? Do I want to be on the clinical side? That’s the first place to start, in my opinion.
Stephen Tyrpak [00:11:57]:
From there, I think looking at job descriptions is very helpful. If you were to ask me to list off the twelve job descriptions of quality, it doesn’t exist. There’s hundreds. I mean, the role of quality in each institution is so different. If you read a job description and you’re like, you know what? I think I want to do that. I think I can do that. Apply. I think having an interview and then asking the right questions at that interview, what does my day-to-day look like? How am I actually going to be interacting with other departments? Do I work with other people or am I working by myself? And understanding what you do and do not like, I think is the best place to start there.
Stephen Tyrpak [00:12:34]:
Your second question was, I forgot it already.
Chris Frew [00:12:38]:
It was, where does compliance and auditing fit into that? So you talked about on the floor again, I’m just trying to build a visual for the audience on the different elements.
Stephen Tyrpak [00:12:51]:
So when you look at compliance, some people integrate that into quality, but compliance is really the final check to your regulatory bodies. So your compliance can either be checking your processes and your data to its own internal systems, or your compliance to a regulation. So, for medical device, our quality system here in the US is the 21 CFR part 820. For pharmaceuticals, it’s 21 CFR part 210 into eleven. So the compliance aspect is, okay, we’re doing quality work, but are we doing it in accordance with the requirements? And auditing is an incredible field that I’m one of our auditors here at PQE and I love auditing. Auditing is going into a process or an institution and basically checking. Are they doing what they have written in what we call a standard operating procedure and SOP that they’re going to be doing. And also are their SOPs compliant to the regulation? So, auditing, if you’re interested in travel, some of our auditors travel around the world because we go on behalf of our clients to make sure that their suppliers and that their customers, not customers, but their people, they’re buying them from their suppliers, are being compliant because you as a manufacturer are responsible for all the quality of all the institutions that feed into your final product.
Stephen Tyrpak [00:14:09]:
So auditing is a great field. It’s a difficult field. It’s a lot of work, a lot of, again, thankless jobs sometimes, but it’s definitely that final checkpoint of are we doing what we say we’re going to do, and is what we’re doing compliant to the regulation?
Chris Frew [00:14:25]:
Yeah. So you just brought something up that that’s more of like a regulatory side. Where’s the division line between regulatory and quality? Or is it just blended?
Stephen Tyrpak [00:14:37]:
And this is where, back to the JB and the interviews. Every organization blends the line of RA and QA sometimes. And sometimes there’s a very clear line. So that regulatory aspect, if you’re not familiar with the language, that is people who deal specifically with regulators. So people who are designing the strategy for your go to market, the people who are speaking with the agencies, the people who are really doing the final check to the regulation, those are regulatory. Some people combine their QA and RA into one person, one division. Some people like to have very separate and individual avenues. So it’s really up to the organization.
Stephen Tyrpak [00:15:16]:
A lot of times, academia, startups, they’ll have an RAQA. When I worked in the startup world, I was RAQA clinical, and I did it all because I had to. I learned a lot, but you do it all, so you just need to check quality regulatory, you just have to. But bigger institutions have siloed departments, and I think that’s more appropriate to have those more siloed. But yeah, it’s up to the institution.
Chris Frew [00:15:41]:
It might be the earlier stage of the company. I think the more hats you wear, right? Isn’t that the rule?
Stephen Tyrpak [00:15:48]:
Correct. If you don’t have at least, and we used to have hats that we would put on, so you would take one hat off and put the next one on. And I think for people who want to learn the field, startups are the best place to be because you do get to see every aspect of the manufacturing process. It’s not easy. And I think startups are getting more and more difficult with where our economy is, but I think it’s rewarding.
Chris Frew [00:16:12]:
Well, that’s why they have a startup guru like you that can come in and help understand what the playing field looks like in quality, so they can make it a little bit easier. Because you’re right, it’s been a tough go at things, but yeah, that’s interesting. So again, if regulatory is ensuring the right regulations and quality is implementing them, you probably do need to look at it from two different perspectives. Yeah, I bet. Another way to learn a lot about the quality field is as a PQE consultant, you probably work with a lot of different customers. You do.
Stephen Tyrpak [00:16:47]:
And the nice thing with a consulting company, whether it’s PQE or someone else, especially a global one, is I’ve been exposed to quality in different countries. So in my mind, a quality product is a quality product. There should be no difference. So out of my ignorance many moons ago, before I understood European and Japanese and Australian and all these different countries’ quality systems, I assumed that they were all the same. I just assumed that it was universal. But getting to work with companies around the globe, there’s a challenge in quality, that you need to have one system that may comply to twelve ever-changing requirements. So it’s something that quality is always changing, which is never really a good thing. For quality, you want consistency, you want the same rules and regulations.
Stephen Tyrpak [00:17:34]:
But working for a company like PQE, I’ve been able to learn a lot about global quality, about understanding what it takes to bring a product to multiple markets. So I think it’s definitely a rewarding field. And like I said, if any PQE people here. Thank you, thank you. I like my job. Please don’t get rid of me. But.
Chris Frew [00:17:55]:
It doesn’t sound like that’s going to happen anytime soon. That’s great. Well, this has been really helpful. Hopefully, this gave a good foundation for our audience around it. I want to take just a quick minute to share a screen if I can. So let me make sure I can do that appropriately.
Stephen Tyrpak [00:18:18]:
And then we’re going to go through the questions on the screen too, Chris, after.
Chris Frew [00:18:21]:
And then we’re going to go right to questions. Yeah, but just to ground everybody in kind of what we were talking about. Let me share this real quick and just 1 second. I will. And then I’ll pull you back on.
Stephen Tyrpak [00:19:13]:
CQV. We’re looking at commissioning qualifications. That’s how equipment manufacturing quality compliance is pretty self-explanatory. Laboratory excellence. People who come out of academia, specifically like in biochemistry, genomics, they typically really like the laboratory excellence aspect in pharmaceutical companies. They need people in quality to check the stability, the characterization of their pharmaceutical products and the quality of those laboratories is very important and very highly regulated by the FDA. Data integrity. Like I mentioned earlier, you are only as good as your data.
Stephen Tyrpak [00:19:54]:
If you can’t maintain it and validate it to show that it’s secure and unchangeable, your organization won’t be able to do much. Digital governance is how you govern that model. And we also do training. So we don’t want to train small, medium, large companies on different quality aspects, different regulations, different standards, things like that, and pharmacovigilance. That is actually the quality assurance for CSV of pharmaceuticals. And then quality culture, our big initiative. And what I thought last was you could have good quality systems, but the culture of organization is not built to facilitate that. And you’re really pushing for organizations to build a culture, not just a system.
Stephen Tyrpak [00:20:42]:
In the conversation, we had other hours of build how that implemented. But thing to really think about when you’re looking at interviewer, ask about their quality initiatives. Every big organization has one. And really ask them what’s important to them, what are they pushing for in the next coming years and what changes do they want to see in their organization in quality, because understanding where they’re going to be and how you can play a role in that is very important, especially when you’re trying to picture if you can fit in that role in that organization. That’s what I have for the screen. Chris, what else would you want me to talk about? That’s good.
Chris Frew [00:21:21]:
That’s great. I really appreciate that. Well, let’s move on to some questions here. And I think that’s a good starting point. One of the questions that came in here today was what is the best way to prepare for a technical interview session in quality?
Stephen Tyrpak [00:21:42]:
Yeah. So when I say prepare, and this is where I always try to be realistic, some people try to just, if they see the JD has a specific requirement for a regulation or a quality requirement, they’ll go read that and really try to be pros on something that maybe they’re not a pro on. I always suggest when you go to an interview, go into it realistic with how you can integrate your experience, your expertise for what they’re looking for. So when you’re going in for an interview, understand the job description, understand how you feel you can fit that, maybe freshen up on regulations and quality. But don’t try to just say the right things, to say the right things. And that’s for two reasons. One, if you have an interviewer like me, and I’ve been told I’m a very difficult interviewer, I’ll be able to know if you’re actually experienced or not because quality is about processes and understanding how to implement. But number two, the worst case is that you get the job and then you can’t do it.
Stephen Tyrpak [00:22:41]:
And when it comes to quality, there’s a lot of nuances that if you’re trying to sell yourself as a more senior person and the role is above you, it’s not going to be good for you or the organization. So I think it’s be realistic. Do a little bit of freshening up and really understand how to portray your value to the role. But don’t try to just get a role to get a role. I guess that’s my best advice.
Chris Frew [00:23:03]:
Yeah, that’s great. Just building on top of that.
Stephen Tyrpak [00:23:11]:
Are.
Chris Frew [00:23:12]:
There any examples that you can provide, like what people should talk about, share experiences if they have a bin quality, different ways they can show that mindset that you would recommend.
Stephen Tyrpak [00:23:25]:
Specifically, when people come out of academia or other industries, quality can be found in any industry. I mean, if you worked in food service, there is quality controls in place in food services. So I mean, it’s understanding that every part of your job you’re able to portray a sense of quality. So if you’re coming from a nonregulated industry and you want to get into the quality field, I would definitely have examples of how you feel in your previous position or in your world. You’ve been able to live that life. Quality fit the regulation that you’re trying to comply to. A lot of people coming out of academia research, there’s quality controls in your data integrity that you’re doing for your publications, for your thesis. I think understanding how to provide examples that show that you’re living what quality is, is very important.
Stephen Tyrpak [00:24:15]:
I think it’s very realistic and I think it’s also very important that when you use these examples, they should be real. I’ve gone through interviews where people bring me examples and I could tell that they just googled an example of quality. And like I said, if it’s a good interviewer, they’re going to pick a little bit. And if you can’t actually give the end or the beginning of that story, it’s not going to look great.
Chris Frew [00:24:38]:
Yeah, that’s a good point. Authenticity is really important because eventually they’re going to get the job and if they can’t do what they say they were going to do, it’s going to come out correct one way or another. So you kind of touched on this a little bit. But one of the other questions came in from Sarah Fox. She said, what advice would you give a trained research scientist in biology who spent many years as a teacher into a quality role?
Stephen Tyrpak [00:25:06]:
So for Sarah, I think what I would do is, and I don’t know exactly where in biology you were. So if you were in the biochemistry world or if you were in proteins or synthesis, the first thing I would do is try to understand what manufacturers or what developers are working on things similar to your experience. The first place I would start is either in their lab, so I would either get in as a lab tech to understand where you can correlate your experience. Because working with lab equipment in the research scientist world and the manufacturing is very similar. We’re using pipettes, we’re using autoclaves, we’re using titrations, dilutions. I mean, these are all things that we learn and now implementing it, trying to find people who match your expertise. The quality aspect, you might have to start at a lower level, being more of just that hands on quality technician. But that’s a good place to get into the industry is to really heavy on the lab excellence part, low on the quality, but then growing into the quality, if that’s where you see yourself.
Stephen Tyrpak [00:26:07]:
But even just lab technicians, there’s huge careers in pharmaceuticals and manufacturers of medical devices. But really being able to find an organization that meets with what you’re looking for, because every pharmaceutical biotech company is looking for a specific, nuanced expertise, like bacteria. There’s a huge amount of work in bacteria in both medical device and manufacturers of pharmaceuticals.
Chris Frew [00:26:32]:
Yeah. I wonder also just unpacking that some more as a teacher, I wonder what qualities that a teacher would bring also.
Stephen Tyrpak [00:26:39]:
That would be important training programs. That’s a good point, Chris. If you’re a teacher and you can go in and, I mean, there’s typically a full department for training. I mean, our training of our quality systems are as important as the quality system. So leveraging that is good. I focus on the bio part, so. Good. Catch on that one.
Chris Frew [00:26:59]:
Yeah.
Stephen Tyrpak [00:27:00]:
Are very valuable in quality.
Chris Frew [00:27:05]:
And I remember being a teacher and maybe this was just me, but I remember my teacher keeping me in line quite a bit. So quality mindset. I bet my teacher knows how to keep the plant in line.
Stephen Tyrpak [00:27:17]:
Correct.
Chris Frew [00:27:21]:
Terrific. So we had another question came in from Precious Etinosa, who is a PhD in material science and engineering.
Stephen Tyrpak [00:27:31]:
Curious.
Chris Frew [00:27:32]:
His research focus was on bone, tissue and engineering and wants to know any roles that might kind of with his as he looks to transition?
Stephen Tyrpak [00:27:42]:
Yeah, the question is. Good. So one thing that I will say is there’s two different avenues I see here. So for bone tissue specifically, there’s a lot of what I call hard medical device companies looking for that type of experience because understanding how their products integrate into bone tissue is very important. And the FDA and other industries look at that a lot. So I would ask one if you’re into the R D sector and you still want to stay in that research realm, there’s whole departments focused on R D and how to develop and looking at biocompatibility and all the qualified things navigate. I’d give an organization that really needs that knowledge to grow their industry. But again, that could be anywhere.
Stephen Tyrpak [00:28:34]:
From that hands-on quality person who can be doing the testing to doing the quality checks, or all the way up to developing systems to manage what they’re doing. I think understanding the scientific part is sometimes a lot of quality people don’t have that. So that’s a very unique skill set that I think would add a lot of value to companies. So it’s finding the right JD for that. But yeah, you have huge career if that’s what you’re looking for.
Chris Frew [00:29:00]:
Yeah, that’s really interesting. And the regenerative medicine field is really growing and I see a lot around bone and tissue in that for sure. So another question came in from Carsten, and given how rapidly guidance are changing, updating it seems like a fundamental shift in how we’re approaching risk and it’s really starting to become more important. So any thoughts on how to best implement risk aware mentality as opposed to risk averse mentality?
Stephen Tyrpak [00:29:37]:
Yeah, and when I work with organizations, risk is the first thing that we’ll assess. So how an organization views their risk of their product or procedures is fundamental in their quality system. What I will say is the quality and the regulations that are shifting, you’ll notice that all the shifts are only building upon. They’re never removing risk. So it’s not like they’re coming in and saying, okay, you do a risk assessment this way, we want you to do it a different way. What the organizations have, the regulators are trying to do is really build upon putting more safeguards, better defining how risk is done. But at the end of the day, it’s up to the organization to take that regulation and build a risk program that fits their institution, their culture of their people, their products, their potential risk to the patient. So when you’re looking at what you’re building up in terms of an organization, I think risk has to be on both ends.
Stephen Tyrpak [00:30:33]:
So I think the question says, should you focus more on preventative or reactionary? And I think risk needs to be in every decision that an organization makes. So I think although regulations and quality standards are changing, it’s only making things more risk-averse. So how do we prevent issues happening? So, yeah, it’s an interesting world we’re in right now when it comes to risk. And medical device just got a revamp of their big standard for risk and pharma is getting more guidance and I think it’s a good time to get into quality, if you’re interested, because things are getting more clear where before it was. Be risk-averse and show us how you’re doing it. Now the agencies are being more. This is what we’d like to see. Show us how you’re doing it.
Stephen Tyrpak [00:31:16]:
So it’s interesting for sure. I actually lost your audio, Chris.
Chris Frew [00:31:33]:
Sorry about that. My question for you, Stephen, was is that because regulatory agencies now have longer-term data that they’re looking at or that’s because they’re learning more about some of these fields that are innovating over the past couple of years, what’s causing?
Stephen Tyrpak [00:31:50]:
I think it comes to a couple of different things. One, regulators can’t keep up with the innovation. So when you look at things like automation, when you look at things like AI, machine learning, the systems we had 15 years ago cannot keep up with it. I mean, the regulations and the quality standards are not where they needed to be. So a lot of it is them having to react changes in the industry. But two, I think it’s exactly what you just said. There’s more data sets, they’ve seen what works and what doesn’t work. I mean, when you look at the fact, a stat that I presented last week, they’ve been doing inspections for decades.
Stephen Tyrpak [00:32:22]:
The amount of deficiency letters in 483s has not gone down. So we are doing all these inspections and we’re trying to get your quality systems up to speed, but no matter how much they’re doing, it’s not fixing the problem. So I think them trying to focus more on risk-averse and quality culture, it’s putting it more on the organizations to manage their quality and trying to give them more tools to do so.
Chris Frew [00:32:45]:
Yeah, there’s a lot of innovation happening, that’s for sure. I can imagine as regular data, it is tough to keep up as a startup or as a business, it’s just tough to keep up with all the new things you have to think about. I mean, all the new tools that are using AI right now, I’m sure that’s just causing a nightmare for a lot of departments.
Stephen Tyrpak [00:33:05]:
So I love it. I stay up late at night and that’s what I think about is AI and how it impacts manufacturing and quality. But even the regulators last week were all saying it’s hard to keep up with it because even looking at an automated pharmaceutical filling system, when you validate it and think you understand it, it’s doing something completely different the next day. It’s hard to keep up with for sure. I’m interested to see where it heads. I think we’re only in the beginning of it for sure.
Chris Frew [00:33:30]:
It’s going to be a wild ride. So a couple more questions for you. This is great, by the way, also, I mean, thank you very much, Stephen. This is a really great conversation. We’re getting a lot of engagement online. So we had another question come in. Yvonne said, I’m trying for a higher level role in biotech pharma, like senior manager or associate director. Any advice? Do you find certifications make any significant difference?
Stephen Tyrpak [00:33:57]:
What was the last part?
Chris Frew [00:33:59]:
Do you find that certifications make any difference?
Stephen Tyrpak [00:34:02]:
Yeah. So for certain jobs you need things like PMPs, you need things like ASQ auditors. I think certain jobs and functions, certifications definitely do help in terms of rising in the ranks and specifically quality. There’s two things that I have found in my colleagues and friends that I know are still in the industry is, number one, you need to master your field. So I think one of the parts is just really staying up to date with quality regulations, how they interpret it, staying up with trends, being part of conversations like this to see what others are doing right and wrong. But number two is no one’s going to hand you anything. You need to put yourself in a position where you are really fighting for what you think you deserve. I think it’s unrealistic if you’ve been doing it for two years to think you can be a senior manager.
Stephen Tyrpak [00:34:52]:
But if you have the experience, you need to communicate that to your supervisors and to your bosses. And if they’re posting jobs, if you’re at a big organization and they’re posting jobs you think you’re fit for, really fight for that. Because I have found in my life no one’s going to hand you anything. You really need to be your own advocate for those and really be the champion for yourself because no one’s going to do it for you.
Chris Frew [00:35:14]:
That’s great advice. Early on in my career, a mentor said that to me, said you have to be your own biggest advocate throughout your whole career.
Stephen Tyrpak [00:35:26]:
Yeah.
Chris Frew [00:35:27]:
Another question about transitioning, which seems to be like a lot of interest in transitioning to quality. So that’s good for the field. Scott Picor had that. He has many years in biomanufacturing and would like to shift into the quality field, but hasn’t had luck. Any advice you’d be willing to share around what Scott could do? Either maybe from aligning his resume with the right job or just in general presenting himself from the right interview?
Stephen Tyrpak [00:35:58]:
Yeah. If you’re in manufacturing, you’ve seen quality. So hopefully, let me say that first, I think if you’re manufacturing it, you’ve seen the quality. If your organization is not really allowing you to get into that quality world where it’s not conducive or a lot of times I see where they need you too much on the floor, so they’re not going to let you grow into the quality side and you’re looking for a new job. I think in your resume you can always speak to the qualities that you have worked in. So if you’ve worked in a part 211 facility and you’ve been able to work with Kappas, or maybe you weren’t leading it, but you were exposed to it, if you’re willing to kind of start back at the bottom of that totem pole, as we say, that’s a great place to start. If you have mastered those quality systems and you are, even though you maybe didn’t lead the process, but you can really speak to it educatedly and you think you can lead it, you can always say that you’re proficient in, I mean, that maybe at least gets you in the interview. Don’t lie.
Stephen Tyrpak [00:36:56]:
I mean, if you’re a manufacturer, you can’t say that you led the quality process for Kappas or something like that, but I think saying you’re proficient in something might get you in the door or wording it a little bit around there is outlining those areas that you think you are capable of. I hope that helped. It really depends on what your experience is and what you’re manufacturing, but there’s always ways to shape your resume and be realistic, but also what I call positively optimistic.
Chris Frew [00:37:23]:
I like that. I’ve always found if you look at the job you’re applying for and you start to use the language they’re using and how you describe, again, not thing, but use that same language for how you describe the work you did.
Stephen Tyrpak [00:37:40]:
And our recruit team hate me for saying this because this is the trade secret. But your resume should be altered for every job you’re applying to. I mean, the people who send me the same resume for twelve different jobs, it’s the same resume. First of all, if I was to send you my resume the same for every job, I’d be doing myself a disservice, because there’s things that I don’t put on every time. But you really should be considering that. Send your cover letter, alter your resume for the job description. Show us that you’re not just sending out a million applications. Show us that you’ve given us the thought to investigate into our roles and that you want that position, because that makes it easier for us to say, I want to have a conversation with you.
Chris Frew [00:38:19]:
Yeah, that’s a great point. We see that as recruiters, we see that all the time. People have one resume and they’re applying for a research associate role, and then they’re applying for a QC supervisor role, and you’re like, you could have skills that apply to both, but if you don’t showcase.
Stephen Tyrpak [00:38:36]:
And the last job I almost took before joining PQB, I was offered the job, but I said no. I actually applied to four jobs, the same institution, and each one had a different resume. The reason called me for the last one was not that one resume worked for them, but they actually saw between all four of them, I met the criteria for a completely different role. So it gives you a benefit to really show them everything you’ve done. So, two cents, I guess.
Chris Frew [00:39:00]:
Great story. Sell great.
Stephen Tyrpak [00:39:06]:
So.
Chris Frew [00:39:11]:
Victoria submitted a question. Also, in your experience, does the role of quality specialist, like a QC specialist, vary from one organization to another? And if so, what are some key skills that you need for a QC specialist role?
Stephen Tyrpak [00:39:27]:
The issue with QC specialists is even within an organization, they may have ten different QC specialists. It really depends on the process. So the similarities, and if you are a QC specialist and you want to transfer to a different one, your key functions are going to be the same. You are doing quality control for a process or product that’s going to be the same, but specifically what you do. I mean, if you’re in in vitro diagnostics, you might be doing dilution sets for a panel. If you’re in orthopedics, you might be doing measurements of that knee replacement. I mean, QC specialist is very unique to the specific area that, but the function should be fairly translatable. One issue I find is sometimes companies don’t know what to call a position.
Stephen Tyrpak [00:40:10]:
That’s the other issue. So make sure that you understand, if you’re looking for a QC specialist role, what your definition of that is, and make sure that that matches your job description.
Chris Frew [00:40:21]:
That’s great. I’m going to make sure that when I’m working with a client, because I get clients all the time who give me a QC job or a quality job, and it’s got 100 jobs packed into one that I’m going to say you needed to call Steven first to vet this job description before we start recruiting on.
Stephen Tyrpak [00:40:37]:
It drives me nuts. The one time I saw a role that was clearly for, like, a manager of something, and it was just QC specialist, and I said, that’s, first of all, you have the wrong people applying and you have the wrong pay rate here.
Chris Frew [00:40:47]:
But, yeah, so true.
Stephen Tyrpak [00:40:49]:
Yeah.
Chris Frew [00:40:50]:
And so QC specialists, too. So you’re doing often testing, right, your quality testing, so you have in process testing, or you could have, like, in vitro testing, or you could do environmental monitoring, microbiology. So I think reading the job description to understand what role that QC specialist has within the organization is important.
Stephen Tyrpak [00:41:12]:
Agreed.
Chris Frew [00:41:14]:
Wonderful. Well, this has been a fantastic discussion. I’ve really enjoyed it. We’ve got a lot of engagement online. So again, these conversations, we hope, are helping to people, helping people guide some of their careers, some of how they’re applying, giving them a little extra edge so that they have some of the inside baseball to apply for the job and get noticed over other candidates, because it is, it’s a tough market right now. So I guess just in wrapping up and keeping an eye on the clock here for everyone’s time. Any closing thoughts from you? Just around why choose a career in quality? And who should choose a career in quality? Or if you’d like to take it this way, too, for PQE, why choose a career PQE?
Stephen Tyrpak [00:41:59]:
I’ll give both answers. I think quality is a career that I never actually thought I would end up in. I thought quality was like the boring, meticulous, too much paperwork job. But I have seen what impact quality has on patient lives. I originally went to medical school and I wanted to be a doctor, and I decided that that wasn’t for me. But the point was I wanted to make an impact in people’s lives. And I have seen firsthand the impact that quality has on organizations, on patients lives. And it’s also a very challenging and rewarding field.
Stephen Tyrpak [00:42:31]:
I mean, you get to do a lot of great things every day. Joining PQE, I’m biased, but I work for an amazing organization with great people. I think that we facilitate jobs from small five-person companies all the way up to 10,000. And we’ve been able to really support our clients at a global level. So we always say we like to be global, we treat globally, but we try to do it in a local level. So PQB is great, but quality is great. And I know I’m biased because that’s the point of this conversation. But if you can’t tell, I’m very passionate about what I do.
Stephen Tyrpak [00:43:03]:
And I hope that once you get into these fields and get into this avenues, you start to see that. And if you don’t, it might not be for you. And that’s know, segwaying away from something is not a bad thing. But again, I think quality is great.
Chris Frew [00:43:19]:
Fantastic. Well, PQE has been one of our partners at BioBuzz for several years, so we’re biased too. But we think it’s a great organization and we’re very excited to partner with you. And just again, it shows a lot about the organization that you give your time today to come and talk to others and really kind of be an ambassador for quality and ambassador for PQE to the community. So for that, I really thank you and I appreciate your time.
Stephen Tyrpak [00:43:45]:
And thank you everybody for your great questions. I appreciate those. It was a good conversation. So thanks, Chris, and thank you everybody else.
Chris Frew [00:43:51]:
Have a great rest of the wonderful. So, and again, for everybody listening today, if you are looking to get your job going, I’d encourage you to sign up for the talent lab. We’re in beta right now, but the talent lab will be able to provide you access to consulting, contract, even part-time jobs in quality. So an opportunity for also students who might want to get a project or two under their belt as they’re transitioning. We’re going to be doing these events every week to continue to build insights around careers and help give you the pathways. Next week, we’re going to be talking about flow cytometry. So another really interesting topic that we’re seeing a lot of job descriptions built around, especially with cell and gene therapy these days. So that might not be this audience here, but please share it with your friends and have them come join.
Chris Frew [00:44:40]:
So with that, Stephen, again, thank you so much for your time, and we will sign off today until next week. Thank you.
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