Mastering Quality & Regulation Across Continents With John McKay

John McKay: 0:00

So think of it from a quality point of view, you have a quality plan, right? If you don't have a quality plan, you can go into something and make mistakes or not have things. And so the whole idea of you want to do as many preventive actions, so you have very little

Harsh Thakkar: 0:11

What's up everybody, this is harsh from qualtivate.com. And you're listening to the life sciences 360 podcast. On this show, I chat with industry experts and thought leaders to learn about their stories, ideas and insights, and how their role helps bring new therapies to patients. Thanks for joining us. Let's dive in. All right, welcome to another episode of Life Sciences 360. My guest today is John McKay. He is the President Chief Operating quality and Regulatory Affairs Officer at Q1 Associates LLC, and you're in San Diego, right? Is that correct?

John McKay: 0:46

Yes. Beautiful San Diego.

Harsh Thakkar: 0:47

Yeah. Welcome to the show. How are you doing?

John McKay: 0:49

I'm doing great, Harsh, it's always a pleasure to connect with you. I follow your feeds, I follow everything you do. So it's an honor, and a pleasure to meet with you.

Harsh Thakkar: 0:58

Oh, thank you. Thank you. I want to ask first thing to you. I'm in my mid 30s. You have like 35-40 years, I don't even know somewhere in that ballpark. So you have as much experience as I've been alive

John McKay: 1:11

on planet Earth. Yeah, so that's you know what that makes me a wise Jedi Master who's on the Jedi Council how about that? Okay,

Harsh Thakkar: 1:23

yeah, I want to ask you, I know you work. You're one of the few people in my network that has worked in a lot of different countries. In the past, I had some, I had another guest on the show who had left US and worked at some life science companies in Europe. And we talked about, you know, how how he went through that. So personal story I, during COVID, a company contacted me from Germany. And they were looking for a director of QA role. And the arrangement was like, Hey, as long as like COVID is still going so you can be remote like you can work from US? Well, once everything is like open, the borders are open, and flying is all fine. We will apply for your visa and the expectation is that you're going to move with your family to Germany to work here. And I thought about it, I looked at places to rent, I looked at the office location, I looked at all the logistics. But eventually I decided that it wasn't the best thing for my my family and you know, my wife side of things. So the question I have to ask you is, which was a first role that you took outside of US? And can you walk me through what was going on in your mind, I'm sure you are livid, scared or nervous of taking something and leaving US and going abroad.

John McKay: 2:48

So I was never scared to do that. So I just little background, I was raised by a person that was in the Army who's in Special Forces, paratroopers, 82nd airborne, who lived around the world. And Rick raised me with I'll say, let's say military good and best practices, with the whole idea that when one day you make may work in another country, I was I was actually accepted by the Naval Academy. Do go. But But um, and but it was an honor to be accepted. But so I always had expectations, even as always high school that I would be living outside the United States, at some point, saw I had a global view of the world, and have had relatives and business professionals that mentored me that were already worked with all over the world, whether they were in the military, whether they were working for a life sciences company, whether they were having their own export import business. So since since like eighth grade, I've been exposed to people on a global basis. I also grew up in an area in Maryland, where we had a very diverse community, people from all over the world, we on a regular basis, expats come into our community with their children. And in any day, you could have someone from India or from China or from from wherever joining your class, you know, you knew they were going to be there for like three years. So you, you kind of work with them, got to know them. And you were enriched by them, at least I was enriched by them. So I had a global worldview. As soon as I started my professional career, and I knew that being being a chemical engineering, being in quality assurance, regulatory affairs, operational excellence, which is where my areas are, I knew that if I worked for a company large enough, it's probably going to have at a minimum suppliers around the world certainly could have facilities around the world. So So I came into this at a totally different viewpoint than some of my peers, who I would say a very provincial may have never left the state of Maryland. Nothing. Well, within just a different point of view, we're all different, but have a very provincial okay US focused state focus view versus a global view. So that That's that inches mean to why I've worked in four countries with four expat positions. And why I've done projects in 32 countries, because I sought after those opportunities, as well as those opportunities sought after me, and I was doing it at a time with very few people would would are willing to do that was now post COVID, people can work from all over the world, especially in do things remotely before COVID. That was almost unheard of. So. So that's a little background about that. So I've I've had expat positions in UK, Germany, Brazil, and China, four very different countries to different companies, and different responsibilities. But I've done product launches, audits, gap analyses, operational excellence engagements, and let's just say training of a third parties like CMOs, CDMOs, CROs, CLOs and 32 different countries here. And so I've been enriched by that, because everywhere, every time you expose someone, every time you meet someone, you they learn from you you learn from from them, and you're enriched. And so I am fully enriched, if you look at my chemical engineers, we look at this, from a chemical reaction point of view, my reaction has been enriched by four by living and working in four countries. And by doing projects in 32. And by projects, I mean, a week to a month, right and duration, sometimes longer, but but projects will say a week to a month long, where where's the live in the countries is for long time, my most recent Express was in China, which which was like living on a different planet, in a good way. And we could talk about that. But yeah, it was so much different than, than the UK, Germany, Brazil, and the UK is almost like an extension of United States. US is a former colony of the UK. So we don't still like to think of it that way. But that's the truth. So it was almost like an extension of the United States. Germany was very different. There's, there's very different types of people in Germany, there's like, just like this Do or Die peeps, in United States, there's like, you know, I will say, progressive people in Germany, and let's say not so progressive people, just like those in the United States, Brazil, it was utopia, I could have died and gone to heaven in Brazil. And then China was second largest economy in the world. 80% of our API's come from China and India. So you have that experience. And so although I haven't lived in India, have probably had the most trips to India, with the exception of China, as far as it's going back and forth on projects and work with suppliers. I even have a a training program that I do on managing suppliers in India, and China, because that's a that has become very specialized craft if you are in specialized systems.

Harsh Thakkar: 7:44

All right. And and with all this experience that you had, I wanted to pick on on one topic. So being working in different countries, obviously, there's culture and you still have to get the job done, you still have to get the project goals done. So if let's say you already worked in so many countries, and let's say tomorrow, or next week, you're going to a completely new country that you haven't been to on a new assignment. What do you so quality, you work in quality, operational excellence, a lot of the things that are done within quality, whether you do it in Egypt, or India or US they stay the same, right? Quality cannot it's not reinvented for every different country, the fundamentals are still the same. It's just how you get the job done, and how do you interact with people? So my question to you is, picture this, that you are going to a completely new country that you haven't been to, but you're not scared, you're just happy that you're going there. You're excited? What do you do in the first, like two weeks or 30 days? Do you like start reaching out to people at that company from US? Or what is it that you do different when you get there, so that they welcome you? They include you in that system? Now you're running like a well oiled

John McKay: 9:07

That yeah, I'm glad you asked that Harsh, there's a machine? whole process to that, that starts one to two months before you even get on an airplane. And it's something that I've done now 40 times, so I've kind of perfected it. But what happens is, it also is something that if you don't do it, there's going to be a lot of unnecessarily trial and error and mistakes, just like any other process. So think of it from a quality point of view, you have a quality plan, right? If you don't have a quality plan, you can go into something and make mistakes or not have things and so the whole idea of you want to do as many preventive actions, so you have very little corrective actions as far as going interesting. And so it's a process that I learned a long time ago from a very large global pharmaceutical company that basically had a saying that the sun never sets on this company, meaning we have facilities we have so many facilities around the world, that every, every hour of every day, someone's working at a facility of ours. And so there were a lot of different opportunities to, to, to work and to do that, but they had a process where anyone that was going to go abroad meaning leave, leaving their home country to another country, basically had had to sit through a training course that taught them about the country that they were going to go to talking about customs there, there's no way there's an expectation to pick up the language all the time, but a few few expressions, few key expressions, you want to know from some niceties for icebreaking. And in particular information about the the customs there, the the systems that they have in place holidays that you may encounter while you're there, because that can affect people attending meetings have you also have information about community events, whether it's for the country or whether community you going to a relationship vents, because again, these can have implications to work. A visit to the US State Department website, because some places just aren't as safe. You know, people are afraid United States we have we have some issues here today. But you know, some places, you know, they may may be some issues where you may just want to be aware of things from a travel point of view, from safety point of view. And then the meat and potatoes of why you are going there what you have to do who you have to meet what your assignment is, and what your goals and objectives are for that. And so then this starts one one or two months, before you go, do you have to get a visa? Or do you have to do something else? I remember a colleague of mine from a company I won't mention it, from Germany showed up in Brazil did not have a visa because he just in his mind could never imagine that Brazil would what somebody from Germany, they have a visa coming there. Well guess what they do. So with that person was detained for like three days, and we were thinking, I remember scratch their heads, like, you know, he kind of he kind of didn't listen to the training, we said, make sure you check your visa status and whatever. So that that's what I did with three days of wasted he was in a hotel, he was actually in quarantine by the government, they treat them nicely, because obviously Germans have done a lot of work with Brazil in the past, but he couldn't leave that hotel until he had an expedited visa, which cost three times the normal amount. And it was only because he worked for a company he worked for that they even granted to him otherwise, he just would have been told you have to go back to Germany. So the visa status is very, very important. I am learning that even for US citizens to go to Europe next year is going to be a special privilege or special permission has to be gotten that was never then we can thank our past president for that whose name I won't mention. But um, yeah, so check checking. Can you actually get into the country? Are you allowed to get into the country should be the first thing on the list? Yeah, for a lot of people. It's the last thing.

Harsh Thakkar: 12:57

Yeah. Yeah, I mean, obviously, you know, even if you're not going for business, you're just traveling for fun or tourist. You still want to check the normal first thing to check. Yeah, is are you can you fly there? Without any

John McKay: 13:09

just sort of the met back in the day. I've had people issue? It's that didn't have a passport, which Okay, nothing. Nothing wrong with that. Just get a passport. But you know, some people still don't have a passport, believe it or not. I mean, I grew up as a child with a passport because my parents got us passports. So yes. So do you have a passport? Do with your country? In order to go to another country? Do you need a visa? And you showed me a very nice very world class system the other day when we were talking about a trip and your family coming up to India. You showed me that so that that website you show me as far as I'm being able to plot your country to another country back in the day I see it often because I'm working long enough to now we have electronic systems like that. That makes it so much easier. But But yeah, you you want to prepare yourself you want you want to have a process of those, I guess a list of eight things. Those are the things that you go through and manage it like a project, because going going to another country, whether you're going to live there if you want to live there. So in total is even more you have to do but if you just want to visit for a week, that's the normal time to go then it's a whole process. So what what you need to do, it has to start, and I say two months at a time. One, if you find out today, you have to go to another country. Hopefully you have two months but if you don't you have to do that in a expeditious manner, a fast manner.

Harsh Thakkar: 14:29

Yeah, I haven't been in that situation. I mean, I travel for maybe like a one week or two week projects. It's never permanent. But what I wanted to ask you more so let's say you you worked in US and then you go and work in maybe a different country. Do you have any like stories or any experiences where you are stories where you were you seen a big like a clear difference in the working style because I'm curious to learn so like for example, in US there's a set way of working or there's a set way of wearing business attire to work or the way you do meetings. So can you talk like maybe in other countries? What was a difference that you saw? Like, oh, yeah, this is really interesting. We don't I've never seen seen this.

John McKay: 15:19

Well, you so I'm glad you asked that question. Because here's what I would advise people expected differences, because guess what, there are differences. And if you want to, if you want to assimilate, if you want to be effective, if you want to be seen as a inspired informed colleague, you need to learn those differences. And, and nowadays, the internet, you know, I started with the way that we That's how seasoned I am. Now, there's internet, now there's places to go, as well as your own company. If you're going to a company facility, that makes it so much easier, because you already have built in systems of people to connect with peer to get information to you're not having to go do this on your own, you're not having to rely on a supplier to do it. But whoever you're going to go visit must. So you're not showing up to a place by yourself, you're going to a facility or an office or whatever. So work with those work with your host, sometimes you have to do that to get an invitation letter but work with your host? To let them know, I'm open to the customs? I'm open to learning what the ways of working I'm open to ideas, can you give me a little primer maybe set up a video meeting, half hour, half hour 30 minute video meeting or if there's like a visitor package that you have many places that receive a lot of audits or gap analyses like CMOs, CDMOs, They have visitor packages if you ask them they give it to you sometimes if you don't ask for it, they forget you don't have it and then they don't give it to you but ask for the visitor package. And it's a visit package doesn't have everything you need go from there but you really it's on the individual to prepare themselves because no one knows without asked you if you've been to that country and not no one knows if you even live in that country. But I've I've a lot lot of stories I mean, countries where I want to say call out specific countries, but I remember working even in chemistry, we had a rule when no alcohol was allowed on site. Well, the exception was France they serve wine during the cafeteria for lunch. And you know the whole lot of people in the states will say you can't No no, this is France they're allowed to do it. The people there have one little wine drink one little sip they they mesh alcohol everything's fine. They're not gonna affect anything good. No other place in the world was allowed to do that. Because it's not a part of the culture even though you have a you know the size a Europe couldn't do it in Italy fought for it. No, that's not true cost. So France, you could have one one little one he had a white one. He had a red wine and they rotated they even had a wine cellar that no there wasn't why so it's totally German too. But they they serve alcohol until after dinner. But the lesson is the custom and another place where they have let's call flex time. I won't mention the country again. But you know, if meetings has been starting,

okay, they may start at 10: 18:04

05 They started 10:10 Because guess what, people are spending the first 10 minutes on pleasantries on icebreaking on on how are you doing? How's your family? It's good to see you John haven't seen you in a while. Hey, hey John's in town first, so you have to you can't like you have to know that the first 10 minutes are going to be social.

Harsh Thakkar: 18:25

Yeah, I know which country you're talking about. And I had to learn that the hard way when I came to you

John McKay: 18:31

both for once you the key about all these is once you know just like your quality, once you know the root cause once you know why it's there, then you have a way to embrace it, you have a way to say okay, that makes sense for them. I see why they do that. And at the end, I'm going to in order for me to assimilate. I'm gonna have to do that now. One should never assimilate into things that makes them feel uncomfortable or is against their religion or against their value system. But most things are most things are, especially in a work environment, if you're going on some tour somewhere, yes, that may do but in a work environment. There's a there's a a band of let's say specifications that most companies follow is that you can assimilate to the culture within that band of specification. So yeah, so So you want to learn those things and get to those things. Another country, they they take naps in the afternoon. And I remember it's the country I lived in. I'm like, Okay, why is everything so quiet at from one to two. It's like this. You could hear a church mouse while walk around like people are actually asleep. I'm like their aloud to sleep here at the desk like this and office, went to the CEOs office. I said, Oh, you're awake. He said, Yeah, you and I are the only one's awake here. You're this because you're not from our country. And I don't have time to take a nap like everyone else. But everyone else supposed to guess what you couldn't do don't schedule a meeting between one and two? Because most likely people will be asleep or they're come they're grouchy saying you're interfering with they won't they're polite. They won't say it but they are thinking this knucklehead is interfering with my naptime. Right, right? And so it's like I call it the nursery time, because it reminded me of like a, like nursery school where you go and all the kids are asleep. A sshh you got to be quiet naptime, naptime if I didn't tell them this, this is in my mind. And we thinking, Okay, let me let me creep around quietly, you know, not not waking anybody up.

Harsh Thakkar: 20:20

Yeah. And having worked in different countries with different types of quality professionals in all of these countries, what are like, three non negotiables in from your experience that somebody must have, regardless of where they live, in which country where they work, if they're in quality, if they're in like reg affairs, or operational excellence, the areas that you worked in? What are like the three non negotiable traits that maybe you look for when you're hiring?

John McKay: 20:50

Yeah, yeah, there's probably 10 non negotiable but

Harsh Thakkar: 20:51

That's, that's a good point. I'll give three. Yeah, one is, the person has to be a disciple. And follow exactly. All rules, regulations, procedures, systems, because sometimes that can affect their safety or the

John McKay: 21:09

The second thing is you have to be someone that is safety of the product or patients either. So they have adaptable. Not many not a lot of people are adaptable these days to, they have to, like be the top person to follow procedures I'm finding, they like, they like their certain ways they matter fact, I've even seen situations where people were like their order, they know how to handle change. Well, also you invited to be on a team, like no, no, they're not going. Why have to be adaptable, because just a mere fact of getting on aren't they going? because they don't follow procedures, when an airplane to go to another country is already doing some they if they don't force to follow procedures United States, adaptation, being adaptable, being open to change, being able then neither do they in another country, no they can't go find to handle change, being able to handle different things. And the third thing is you have to be, I would say, an open vessel. And somebody else. Yeah. So you have to follow the procedures. Make by that, I mean yes, you're gonna bring your own good best sure you have your training up to date, but make sure you all practices with you. But you have to be receptive to what you're your procedure the following. So that's procedures, customs, going to learn that they have to teach diff a different way of laws, requirements, you have to follow that that's probably the doing things. And openness. Uh, well, you know, I've never seen number one thing because while one could get in legal trouble, it that way. But let's, let's look at this. Maybe that could if you're not, work. Okay, show me how that can work. So being open vessel that people can pour into, if you're not those three things, you're not fit for getting on an airplane and leave the United States or any country you're leaving any country to go to another country.

Harsh Thakkar: 22:52

Yep, those are really great ones. I think my favorite out of those three, again, I'm all three are great. But my personal favorite is just being adaptive. Like, I've seen that in my career, when I was open to change or open to new projects or new opportunities. Sometimes people have this idea of, they want to know what the change will do to them. Right? Like if the change is positive, like, Oh, if I get more money, or if I get a bigger title, or if I get an increase in pay, or if I get a boost in my career, only then I'm going to invest in this change. But it's really hard to do that, at that moment in time where you don't know how that change is gonna pan out. You only know that A.) either this could be the worst thing I'll do or B.) this could be the best thing or C.) is like the middle ground where it was good, but I'm not going to do it again. Right. Yeah. So you always have to agree.

John McKay: 23:51

Yeah, you have to be able to take lemons and make lemonade. Yep, just shortest simplest I can give. There's gonna be things that are good are gonna be things not so good. And will be things that are favorable, some things slightly unfavorable. You have to have a glass half empty. I've been given lemonades when a lemon I wouldn't make lemonade. It's type of personality and type of Outlook so that the overall net is positive for both sides for you and them, and that you, you leave them in a better situation than you arrive, and that they're happy to have you come back. Yep.

Harsh Thakkar: 24:28

I agree with you completely. I want to ask you one more question on the reg Affairs side or more specifically about dealing with regulators or dealing with drug enforcement agencies or whatever whichever country you're working in medical device food nutrition, right? When you are going to a new country, let's say whatever it is, and that client or company that you're working for, like let's say has we have these requirements in our state or we have this requirement at a country level. Sometimes you may or may not not know those like FDA, EU, everyone knows those because they are the big ones. But if you're going to some other country where they need your expertise, how do you learn about those things before you interact with that regulatory person? Or the agency?

John McKay: 25:15

Excellent question. It's under the title of investigative research. So what happens as part of your preparation process, you want to have any any regulatory agency you're dealing with that's different any company you're dealing with, or any let's just say system could be an ISO standard, for example, you're dealing with, you have to do investigative research to learn not only what the requirements are, but to learn what their preferences are, what their incendiaries are, and what their what their pinch points or touch points are. Every agency has that. And so the FDA, EMA and Visa, you know, other other agencies TGA, they're kind enough to tell ahead of time industry, by having conferences by having webinars by having discussions, stuff on their website. Now, agencies are some agencies could be in a different language. So you basically have to work with your partner to ask them, Are you aware of what the agency's top priorities are for this year, or what their focusers are, and if they aren't, they can go get that for you. And because not only will help you to help them, like your colleagues should know that in the foreign country, but you have to do investigative research to do that. And again, this is why I say start two months in advance this, sometimes it takes time, it could take several discussions, some some regulatory agencies in certain parts of the world and certain Asian countries, certain African countries, you know, and even South America countries are not as let's just say, forthcoming with that information. And and many times some may have never been asked that question before. So they have to think about it for a minute so it's your investigative research may take a little bit of time. Whereas in the United States EU, let's just say the g7 regulatory agencies that's easy. They if you're if you're if you're a smart enough to be involved with industry, and association meetings, like right now, for example, as a PDA FTA meeting, I want to be there but I'm helping the cloud off this week meetings like that, when I say any FDA does periodic training webinars, you know, and sorted other agencies, you want to find that out, because that's very important, because it's important to know the regulations. But I will say sometimes it's more important to know those priority areas and those incendiaries because they're coming near loaded to look for that.

Harsh Thakkar: 27:39

Yeah, yeah. And if they've, you want to make sure that whatever whatever story you're you are presenting to them, you have enough objective evidence to line or backup that story, right? Because that's where most companies face a challenge. Because in their mind, the quality executive or the the C level executive has a picture of what's happening. But then you get a regulatory person coming in or auditor saying, Well, John, you told me this is what's going on. But your data says the other you know, completely other side of the story.

John McKay: 28:13

So exactly, the agencies want to know three things. It can they want to know a lot, but it can be boiled down to three things. Are you credible and honest? Do you get it meaning? Are you up on a rags? Are you up when you're priority areas? Do you care enough to be that way? And three? Is their problems? Have you demonstrated that you fix problems in the past so that the current problems are Connery, you either have discovered them and have a cap in place, or they can rely on you to honestly assess it and honestly fix it in a way that they think it should be fixed. If you can do those three things. The rest is cake.

Harsh Thakkar: 28:50

Yep. I agree. I completely agree with that. Well, you know, I know we're up on time. I've really enjoyed this conversation. I had so many questions for you. I think we have to maybe put this out and do a part two or part and a part three. Because I had like 40 questions for you for you. And

John McKay: 29:10

I learned from your questions. So I appreciate your questions. Thank you.

Harsh Thakkar: 29:15

Yeah, so before we close this out, I really want to thank you for coming on. Do you have like Where can people connect with you? Or, or contact you if they want to pick your brain? Or get your help on any projects? What's the best way to connect with you?

John McKay: 29:29

A piece of metadata has never changed for me since 1984. Four countries later 32 countries later is my AOL email address. And it's jmckay@aol.com If you want to find the Jedi master file when or when an AOL email addressed Okay, so they okay can reach me at that anytime. That's the only metadata has never changed. Nowadays you can port your phone and take your your Number with you. So now that's not changing but um, but yeah, the jersey I wear may change the where I'm at may change. I may be all over the world, but you can always reach me by that email address.

Harsh Thakkar: 30:08

Great. And any new any concluding or final thoughts before we wrap this up?

John McKay: 30:13

Yes, yes, I will say the other things the world is truly global. I mean, it's been global since the 80s. But it's really global now. And, and then post COVID, we, as professionals can work remotely, because it's accepted a lot more before COVID. A lot of companies are already doing that. But post COVID, you know, one can work from anywhere for anyone in the world, and then travel to those locations periodically. And so the old saying the world is your oyster is more true today than it's ever has been, as well as not everyone wants to work. Outside the United States. Fortunately, the United States, the largest economy in the world, and there's plenty of opportunities, there a lot of opportunities, but you know, what, go to another state. I know some people that have never left their state. Okay. You know, you can leave Pennsylvania, you can leave Maryland, there's other action elsewhere. So one can have foreign experiences right here in the United States, because the states were very different to.

Harsh Thakkar: 31:14

Yeah, I definitely agree. Because I lived on the East Coast, West Coast. And just that is a lot of difference. Yeah.

John McKay: 31:20

I grew up on East Coast. I live on the West Coast. No, I lived in Middle Tennessee for many years. Yeah, it's three, like three different countries. Really. Yeah. And, and that's fun. I mean, I find that fun. I found it exciting. I find it refreshing, and I welcome it. And for those that don't want to No worries, be skilled in your area you want to stay in and your geographic area will function or wherever. Just continue to progress and be better. So the word for everyone is continual improvement.

Harsh Thakkar: 31:48

All right. Thank you so much, John. Appreciate it. And you have a great week ahead.

John McKay: 31:52

You do the same Harsh. Thank you very much.

Harsh Thakkar: 31:54

Thank you so much for listening. I hope you enjoyed today's episode. Check out the show notes in the description for a full episode summary with all the important links. Share this with a friend on social media and leave us a review on Apple podcasts, Spotify, or wherever you listen to your favorite podcast.