Special Episode Welcoming New Podcast Host Meg Sinclair

We're welcoming a new host to From Lab to Launch! Kelly hands the baton over to Meg Sinclair. Listen in on their conversation about all things podcasting for life sciences, quality and transitioning over the podcast. 

A little about our new host. Meg has over 10 years of experience in Quality Assurance, Regulatory Affairs and Compliance across a range of industries - from non-profits to medical device start-ups.  Like many other Quality professionals who start out in another field or department, Meg found Quality after starting her career in Public Health, but her career path has always been about improving the lives of others which aligns with Qualio’s vision.  Meg started with us in 2020 building out our own Quality System to achieve our ISO 9001 certification, followed by ISO 27001 certification in 2022.  Meg was also an instrumental part of the Qualio Plus program, where we provide the necessary procedures and advisory level guidance to our customers as they’re coming onboard with Qualio.

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez

Transcript

Kelly Stanton: 0:18

Hello everyone and welcome to From Lab to Launch by Qualio. I'm Kelly Stanton and today's episode's gonna be fun. We'll be chatting with Meg Sinclair, who is the manager of Quality Operations here at Qualio.. Meg will be the new host of from Lab to Launch, starting soon. So what better way to introduce her than right here on the podcast? Meg has over 10 years of experience in quality assurance, regulatory affairs and compliance across a range of industries, from nonprofits to medical device startups. Like many other quality professionals who start out in another field or department, Meg found quality after starting her career in public health. But her career path has always been about improving the lives of others, which aligns with Qualio's vision. Meg started with us back in 2020, building out our own quality system to achieve our ISO 9001 certification. Followed on not too long after by our ISO 27001 certification in 2022. MEG was also an instrumental part of the quality of plus program where we provide the necessary procedures and advisory level guidance to our customers as they're coming on board with Qualio. So let's bring her in so you can all get to know her. Hey Meg, thanks for joining me today.

Meg Sinclair: 1:25

Thanks, Kelly. I'm so happy to be here.

Kelly Stanton: 1:27

All right. Well, so tell us a little bit about your background.

Meg Sinclair: 1:31

Sure. As you said, I started my career in public health. One of my first jobs was actually teaching reproductive healthcare in high schools. Um, so that was a fun job and certainly taught me to think on my feet, teaching such a hot topic for high school students. Um, And then from there I did some more public health. I dabbled in social work. I even led, um, a team of case managers for a time. and then in that doing quality assurance as well. making sure the customers, um, that we worked with, who were folks with. Developmental disabilities and intellectual disabilities were getting the care and services they need. That's a really underserved population. so it was really great work to be doing, but hard work to be doing. so from there I pivoted and really that's where I really found quality and kind of, and that compliance piece and from there, just kept growing in the qual quality worlds, working for healthcare and then into industry with a medical device startup, which was really fun and really gave me a lot of opportunity to see the quality system as a whole rather than, I think sometimes quality professionals kind of do just supplier management or just audits, um, or just document control. Being able to do a whole quality system was really fun and Really enhanced my experience as a quality professional.

Kelly Stanton: 2:51

That's awesome. Yeah, it gives you kind of a broad view of the world.

Meg Sinclair: 2:54

I like that you've worn me. Birdseye view, oh, go ahead, sorry. Oh, I like that BirdEye view and that big picture. So being able to see the whole quality system is really fascinating and that. I enjoy that very much.

Kelly Stanton: 3:06

it's good. I think it makes you a better professional when you can see how it all plays together, right? Yes. Since it is all related. Well, you've worn many hats in your time here at Qualio and here you're also about to, uh, put it on another hat as the host of from Lab Launch. Tell us a little bit about you and Qualio and, and, uh, how you got started here and what you've been up to.

Meg Sinclair: 3:27

Sure. I've been a part of the team here at Qualio for about three years. I came on in 2020 the height of that pandemic, and we helped build our own quality management system. And in just three short months from when I started, we got our ISO certification. So that was, uh, a very quick implementation and a quick project. Um, It was, it was that thinking of my feet, I think, from previously in my career really came in handy again. Um, having, being able to adapt quickly, and move quickly on that project was really important and really key to my success here at Qual. and then from there we worked with the IT and engineering, and our security teams to get our iso, certification for 27 0 1. that one wasn't nearly as fast, but. A much easier process having already done 9,001.

Kelly Stanton: 4:18

Yeah. Yeah. The overlap there Sure, sure. Made that a nice addition to the, to the battery, if you will. Yes,

Meg Sinclair: 4:25

yes. That made that much easier. and early, as you earlier, when I was working with Clio, as you said, I was helping with the Plus program, so helping customers implement their own, quality management systems here at Polio, which I enjoyed as well, being able to teach others. Who maybe aren't quality professionals who were just trying to run their own startups during the pandemic, how to implement their systems was a whole bunch of fun

Kelly Stanton: 4:47

too. That was fun. I did enjoy the, that, uh, that part of the job as well. And certainly here at Twilio, what we, we strive to do is, is partner with our customers, help, help advise them, help educate them when they, when they don't know. and, uh, yeah, you were great. You were great for that, for sure. you were instrumental in getting us ISO certified, as you said. That was, uh, you know, it was kind of in process when you got here, but you really picked it up and just. Ran it across the, uh, the end zone there. What was the biggest challenge that, uh, you ran into during that whole process?

Meg Sinclair: 5:19

I think it was, the timeline. Three months is, it's pretty tight. Um, the amount of faith that Qualio put in me though was amazing. I mean, I had all the tools and the leadership and all the cooperation and collaboration I needed to, to help make that happen So that, That made it easy. I think what made it difficult was the timeline and then also trying to learn how to use Twilio while I was implementing our quality system and also trying to reframe my approach on how we needed to operate because we are not industry, we are software as a service. So thinking about it at, 9,001 system and not 13 4 85 or something more prescriptive, For the life sciences industry. So reframing my mind a little bit, I think. Yeah, it's almost,

Kelly Stanton: 6:09

it's almost harder when it, when the standard's a little more broad, isn't it?

Meg Sinclair: 6:13

Yes. It's, I have a lot more room, but what, what is this supposed to

Kelly Stanton: 6:17

look like? It's like, yeah. Is that okay? I don't know. Absolutely. Definitely. Was the 27,001 journey really different, you think, than 9,001?

Meg Sinclair: 6:29

I don't think so. There was a lot of overlap that made that easy. A lot of things that we already had in place because we had already done 9,001. so that made that easy. what might've made it more difficult was our teams, who hadn't been through the ISO process before, getting the, um, up to speed with the level of documentation we needed and how we were going to go through the audit. And just that whole experience, kind of the education there, I think was. Was maybe what took that piece a little bit longer on 27 0 1.

Kelly Stanton: 6:59

Yeah. Yeah. And we definitely rely a little, he more heavily on those technical teams who, think as we all know, are a little resistant to the idea of having to document things or write it down doesn't seem important. Why should I do that? So, yeah.

Meg Sinclair: 7:13

So enabling them to have quality in mind and it's definitely paid off. It's more part of their culture and their work and their day-to-day now than it was before we implemented 27 0 1. So it's been an effort worth, worth taking.

Kelly Stanton: 7:29

Definitely. Definitely. I think it goes a long way with our customer trust too. Absolutely. Well, uh, speaking of the customers, what's your favorite thing about working with the customers?

Meg Sinclair: 7:37

Sure. I often interact with our customers now in supplier qualification process, so quality agreements and customer audits of our system. So it's really fun to show them how our system operates and how we run RN external audits for our customers through Qualio. Because I think it's really great for them to see how streamlined it can be, especially for a remote company like ourselves, that we can run these remote audits and get all the audit outcomes and objectives we need without actually stuffing foot in an office together and spending entire days looking at policies and procedures together. It's a really great use of everybody's time.

Kelly Stanton: 8:19

Well, and I think that probably answers my next question. What's the best part about being fully electronic? I, I think audits are, uh, probably right there at the top of the list, huh?

Meg Sinclair: 8:29

Yes. Especially as you know, we are fully remote. So being across the globe and all over the place in different time zones, it definitely enables us to manage this quality system in a meaningful way. Um, you know, where. We're all on the same page. It's all live. It's not pieces of paper floating across the world. I could not even imagine living in that world anymore. It's a no. That would fully electronic world. That would be a wouldn't. It would be, yeah. And then I think the traceability, being able to link and tie things together and be able to see. Things in that way. in an electronic system where you can tie all the events you need, all the documents you need together, I think that's, and being able to do that in such a flexible way and being creative with your system, I think that's another benefit of being fully electronic where binders

Kelly Stanton: 9:22

and such aren't, Yeah, definitely agree with that. And I would, I would, uh, emphasize that to any of our listeners who are out there doing startups themselves. Go electronic. Go electronic, can't emphasize enough how much easier that makes your life all the way

Meg Sinclair: 9:38

around. Yeah. And we spend more time, I think being able to enable quality, enable our teams to have that quality approach than just simply checking boxes for quality.

Kelly Stanton: 9:48

Yeah. And that's, it's, uh, it's important to get beyond the, the check boxes for sure. Absolutely. Any challenges with being fully electronic

Meg Sinclair: 9:56

or none that, that I can see that outweigh the benefits of, of it for us as a remote company. I couldn't imagine a world where we go back to paper. Or even SharePoint, um, and trying to manage things and in an uncontrolled system, uh, yeah. Yeah. SharePoint don't, oh, I don't have nightmares about that.

Kelly Stanton: 10:17

I know. Same nightmares, same time in industry. Trying to manage it outta SharePoint is just, I feel like Yeah. Talk about being in the trenches. Holy cow. Not fun. All right. Well now it's only fair if we ask you questions to get to know you a little better like we do with our other guests. Um, if you could go back to the start of your career, what would you tell yourself based on what you know now?

Meg Sinclair: 10:40

Learn to code, go to law school. I don't know. Um, no, in all seriousness, I think I would tell myself what will feel like career setbacks. Being laid off a stagnant job market during a recession. Um, when you have poor leadership in a company or you don't agree with decisions being made somewhere in the long run, those are really opportunities. So just to keep growing and keep an open mind and be flexible and adaptable, and you'll be fine. Learning. I wish I would've had that perspective when I was younger. They felt like defeats. But I, looking back now, they feel like these were great opportunities.

Kelly Stanton: 11:20

Nice, What is one piece of advice you would give someone who's starting their career in quality?

Meg Sinclair: 11:25

One piece of advice. I might have two. Um, be creative.

Kelly Stanton: 11:29

It seems okay. We can

Meg Sinclair: 11:30

do two. Okay. One, um, definitely be creative. The regulations are there to be guardrails, but not so prescriptive that they tell you that you have to do all of these things, this sway, and it has to look like this all the time. Be creative about how you write your policies and procedures that give you the flexibility to do the things you need and meet the requirements that you have to need. Just because something is cumbersome doesn't make it compliant, so keeping it simple and being creative and how you implement that and what that looks like, guess would be my advice to somebody in quality. Think outside the box. I like that.

Kelly Stanton: 12:09

Yeah. Don't get, don't get stuck in the box.

Meg Sinclair: 12:12

Yes. And then I think for any career really, um, when you greet a great mentor like yourself, learn all you can from them. So I've had some great mentors like yourself in my career, and really just try to learn everything you can. So you have been instrumental to my growth here at Polio. So I thank you for that. And for anybody out there who comes across to Kelly in their life, I hope they appreciate and learn all they can from them.

Kelly Stanton: 12:37

Thank you. I appreciate that. It's been really fun getting to work with you as well. Switching around to your personal life a little bit, what do you do for fun?

Meg Sinclair: 12:46

I'm based here in Colorado, so in the winter you will find me either skiing or sewing. I do some quilting. Um, And then in the summer and fall, you'll find me gardening or outside birding, hiking and staying active. Um, in the spring, I just kind of hide. I don't like the spring in Colorado, the winds are, are a little much for me. So

Kelly Stanton: 13:07

it is a ridiculously windy today, isn't it? It is. wow. Colorado's a good place to be for a skier, so that's, uh, that's awesome. And if we found you walking around Barnes and Noble, what section would I find you in?

Meg Sinclair: 13:20

Probably in non-fiction, I like a good biography or autobiography. one I read recently was around Cleopatra. Um, and it was just amazing to read all that she was able to accomplish essentially at my age. So, um, she was really inspiring so, always find it interesting to learn about other people's lives, and what made them stronger or what made them really committed to their, their path in life.

Kelly Stanton: 13:44

That's awesome. I love that. All right, well, where can we, where can we find you to, to get connected with you or keep following along with Qualio?

Meg Sinclair: 13:54

Tune into the podcast. I will be here going forward hosting these, and you can find me on LinkedIn. Um, Meg Sinclair, you can put my awesome, my LinkedIn in the show notes.

Kelly Stanton: 14:06

All right. Well, thanks a lot, Meg. I'm excited to pass the torch your way. Thank you.

Meg Sinclair: 14:11

I'm really excited to take this on and have some great conversations with other industry professionals.