0:18

Hello everyone and welcome to From Lab to Launch

0:20

by Qualio. I'm Kelly Stanton and today's

0:22

episode's gonna be fun. We'll be chatting

0:24

with Meg Sinclair, who is the manager of Quality

0:27

Operations here at Qualio.. Meg

0:29

will be the new host of from Lab to Launch,

0:31

starting soon. So what better way

0:33

to introduce her than right here on the podcast?

0:36

Meg has over 10 years of experience in quality

0:39

assurance, regulatory affairs and compliance

0:41

across a range of industries, from

0:43

nonprofits to medical device startups.

0:46

Like many other quality professionals who

0:48

start out in another field or department, Meg

0:50

found quality after starting her career in public

0:52

health. But her career path has always been

0:54

about improving the lives of others, which aligns

0:57

with Qualio's vision. Meg

0:59

started with us back in 2020, building out

1:01

our own quality system to achieve our

1:03

ISO 9001 certification. Followed

1:06

on not too long after by our ISO 27001

1:09

certification in 2022. MEG

1:12

was also an instrumental part of the quality of plus

1:14

program where we provide the necessary

1:16

procedures and advisory level guidance to

1:18

our customers as they're coming on board with

1:20

Qualio. So let's bring her in so you can

1:22

all get to know her. Hey Meg, thanks for joining

1:24

me today.

1:25

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

1:27

All right. Well, so tell us a little

1:29

bit about your background.

1:31

Sure. As you said, I started my career

1:33

in public health. One of my first jobs

1:35

was actually teaching reproductive healthcare

1:38

in high schools. Um, so that

1:40

was a fun job and certainly taught me

1:42

to think on my feet, teaching such

1:44

a hot topic for high school students.

1:47

Um, And then from

1:49

there I did some more public health.

1:51

I dabbled in social work. I

1:53

even led, um, a team of case managers

1:55

for a time. and then in

1:57

that doing quality assurance as well. making

2:00

sure the customers, um, that we worked

2:02

with, who were folks with. Developmental disabilities

2:04

and intellectual disabilities were getting

2:06

the care and services they need. That's a really

2:09

underserved population. so

2:11

it was really great work to be doing,

2:13

but hard work to be doing. so from there

2:15

I pivoted and really that's

2:18

where I really found quality and kind

2:21

of, and that compliance piece and from

2:23

there, just kept growing in the qual quality

2:25

worlds, working for healthcare

2:28

and then into industry with a medical

2:30

device startup, which was really fun and really

2:32

gave me a lot of opportunity to see the quality

2:34

system as a whole rather than, I think

2:36

sometimes quality professionals kind of do

2:38

just supplier management or just audits,

2:41

um, or just document control. Being

2:44

able to do a whole quality system

2:46

was really fun and Really enhanced

2:48

my experience as a quality professional.

2:51

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

2:54

I like that you've worn me. Birdseye view, oh,

2:56

go ahead, sorry. Oh, I like

2:58

that BirdEye view and that big picture. So being

3:00

able to see the whole quality system

3:02

is really fascinating and that.

3:04

I enjoy that very much.

3:06

it's good. I think it makes you a better professional when you can

3:08

see how it all plays together, right? Yes.

3:11

Since it is all related.

3:14

Well, you've worn many hats in your time here at Qualio

3:16

and here you're also about to, uh, put

3:18

it on another hat as the host of from Lab Launch.

3:21

Tell us a little bit about you and Qualio

3:23

and, and, uh, how you got started here and

3:25

what you've been up to.

3:27

Sure. I've been a part of the team here

3:29

at Qualio for about three years. I came on

3:31

in 2020 the height of that

3:33

pandemic, and we helped build

3:35

our own quality management system. And in

3:37

just three short months from when I started,

3:40

we got our ISO certification. So

3:43

that was, uh, a very

3:46

quick implementation and a

3:48

quick project. Um,

3:50

It was, it was that thinking of my feet,

3:52

I think, from previously in my career really came

3:54

in handy again. Um, having, being

3:57

able to adapt quickly, and move quickly on

3:59

that project was really important and really key

4:02

to my success here at Qual. and then from

4:04

there we worked with the IT and engineering,

4:06

and our security teams to get our iso,

4:09

certification for 27 0 1. that

4:11

one wasn't nearly as fast,

4:13

but. A much easier process

4:15

having already done 9,001.

4:18

Yeah. Yeah. The overlap there Sure, sure.

4:20

Made that a nice addition to the, to

4:23

the battery, if you will. Yes,

4:25

yes. That made that much easier. and early,

4:28

as you earlier, when I was working with Clio, as

4:30

you said, I was helping with the Plus program, so helping customers

4:32

implement their own, quality management

4:35

systems here at Polio, which I enjoyed as well,

4:37

being able to teach others. Who

4:39

maybe aren't quality professionals who were

4:42

just trying to run their own startups during the

4:44

pandemic, how to implement their systems

4:46

was a whole bunch of fun

4:47

too. That was fun. I did enjoy

4:49

the, that, uh, that part of the job as well.

4:52

And certainly here at Twilio, what we, we strive

4:54

to do is, is partner with our

4:56

customers, help, help advise them, help

4:58

educate them when they, when they don't know. and,

5:00

uh, yeah, you were great. You were great for

5:02

that, for sure. you were instrumental in

5:04

getting us ISO certified, as you said. That was, uh,

5:06

you know, it was kind of in process when you got here,

5:09

but you really picked it up and just. Ran

5:11

it across the, uh, the end zone

5:13

there. What was the biggest challenge that,

5:15

uh, you ran into during that whole process?

5:19

I think it was, the timeline. Three months

5:21

is, it's pretty tight. Um,

5:24

the amount of faith that Qualio

5:27

put in me though was amazing. I mean, I

5:29

had all the tools and the leadership

5:31

and all the cooperation

5:34

and collaboration I needed to, to help

5:36

make that happen So that, That

5:38

made it easy. I think what made it difficult

5:40

was the timeline and then also trying to

5:43

learn how to use Twilio while

5:45

I was implementing our quality system

5:48

and also trying to reframe my approach

5:50

on how we needed to operate

5:53

because we are not industry, we are software

5:55

as a service. So thinking about

5:58

it at, 9,001 system

6:00

and not 13 4 85 or something more prescriptive,

6:03

For the life sciences industry. So reframing

6:05

my mind a little bit, I think. Yeah,

6:08

it's almost,

6:09

it's almost harder when it, when the standard's

6:11

a little more broad, isn't it?

6:13

Yes. It's, I have a lot more room,

6:15

but what, what is

6:17

this supposed to

6:17

look like? It's like, yeah. Is

6:20

that okay? I don't know. Absolutely.

6:23

Definitely. Was the 27,001

6:25

journey really different, you think,

6:27

than 9,001?

6:29

I don't think so. There was a lot of overlap

6:32

that made that easy. A lot of things that we already had

6:34

in place because we had already done 9,001.

6:37

so that made that easy. what might've

6:39

made it more difficult was our

6:41

teams, who hadn't been through the ISO process

6:43

before, getting the, um, up to speed with the

6:45

level of documentation we needed and

6:47

how we were going to go through

6:50

the audit. And just that whole experience, kind

6:52

of the education there, I think was. Was

6:54

maybe what took that piece a little bit longer on 27

6:56

0 1.

6:59

Yeah. Yeah. And we definitely rely a little, he more

7:01

heavily on those technical teams who, think

7:03

as we all know, are a little resistant

7:06

to the idea of having to document things

7:08

or write it down doesn't seem important. Why should I do

7:10

that? So, yeah.

7:13

So enabling them to

7:15

have quality in mind and it's definitely

7:17

paid off. It's more part of their

7:19

culture and their work and their day-to-day now

7:22

than it was before we implemented 27 0

7:24

1. So it's been

7:26

an effort worth, worth taking.

7:29

Definitely. Definitely. I think it goes

7:31

a long way with our customer trust too. Absolutely. Well,

7:33

uh, speaking of the customers, what's your favorite thing about

7:35

working with the customers?

7:37

Sure. I often

7:39

interact with our customers now in supplier

7:42

qualification process, so quality

7:44

agreements and customer audits

7:47

of our system. So

7:49

it's really fun to show

7:51

them how our system operates and

7:53

how we run RN external audits

7:56

for our customers through Qualio. Because

7:59

I think it's really great for them to see how streamlined

8:01

it can be, especially for a remote company

8:03

like ourselves, that we can run these

8:05

remote audits and get all the audit outcomes

8:07

and objectives we need without actually

8:10

stuffing foot in an office together and spending

8:12

entire days looking at policies

8:15

and procedures together. It's a really

8:17

great use of everybody's time.

8:19

Well, and I think that probably answers my next question.

8:23

What's the best part about being fully electronic?

8:25

I, I think audits are, uh, probably

8:27

right there at the top of the list, huh?

8:29

Yes. Especially as you

8:31

know, we are fully remote. So being

8:33

across the globe and all over the place in

8:35

different time zones, it definitely enables

8:38

us to manage this quality system

8:41

in a meaningful way. Um, you

8:43

know, where. We're all on the same page. It's

8:45

all live. It's not pieces of paper floating

8:48

across the world. I could not

8:50

even imagine living

8:52

in that world anymore. It's

8:55

a no. That would fully electronic world.

8:57

That would be a wouldn't. It would be, yeah.

9:00

And then I think the traceability, being able to

9:02

link and tie things together and be able

9:04

to see. Things in that way.

9:06

in an electronic system where you can tie all

9:09

the events you need, all the documents

9:11

you need together, I think

9:13

that's, and being able to do that in such a

9:15

flexible way and being creative

9:17

with your system, I think that's another benefit

9:20

of being fully electronic where binders

9:22

and such aren't, Yeah,

9:25

definitely agree with that. And I would, I would,

9:27

uh, emphasize that to any of our listeners

9:30

who are out there doing startups themselves.

9:32

Go electronic. Go electronic, can't

9:35

emphasize enough how much easier that makes your life all

9:37

the way

9:38

around. Yeah. And we spend more time,

9:40

I think being able to enable quality, enable

9:42

our teams to have that quality approach than

9:45

just simply checking boxes for

9:47

quality.

9:48

Yeah. And that's, it's, uh, it's important to get

9:50

beyond the, the check boxes for sure. Absolutely.

9:53

Any challenges with being fully electronic

9:56

or none that, that I

9:58

can see that outweigh the benefits of, of

10:01

it for us as a remote company. I couldn't

10:04

imagine a world where we go back to paper. Or

10:06

even SharePoint, um, and trying to

10:08

manage things and in an uncontrolled

10:11

system, uh, yeah. Yeah. SharePoint don't,

10:13

oh, I don't have nightmares

10:15

about that.

10:17

I know. Same nightmares, same time

10:19

in industry. Trying to manage it outta SharePoint is

10:21

just, I feel like Yeah. Talk about

10:24

being in the trenches. Holy cow. Not

10:26

fun. All right. Well now it's only fair if we

10:28

ask you questions to get to know you a little better like we do

10:30

with our other guests. Um,

10:33

if you could go back to the start of your career,

10:35

what would you tell yourself based on what you

10:38

know now?

10:40

Learn to code, go to law school. I

10:42

don't know. Um, no, in

10:44

all seriousness, I think I

10:46

would tell myself what will feel like

10:49

career setbacks. Being laid off

10:51

a stagnant job market during a recession.

10:53

Um, when you have poor leadership

10:56

in a company or you don't agree

10:58

with decisions being made somewhere

11:00

in the long run, those are really opportunities. So

11:04

just to keep growing and keep an open mind

11:06

and be flexible and adaptable, and

11:09

you'll be fine. Learning. I wish

11:11

I would've had that perspective when I was younger.

11:14

They felt like defeats. But I, looking

11:16

back now, they feel like these

11:18

were great opportunities.

11:20

Nice, What is one piece of advice

11:22

you would give someone who's starting their career in

11:24

quality?

11:25

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

11:29

be creative.

11:29

It seems okay. We can

11:30

do two. Okay. One, um,

11:32

definitely be creative. The regulations

11:35

are there to be guardrails, but

11:37

not so prescriptive that they tell you

11:39

that you have to do all of these

11:42

things, this sway, and it has

11:44

to look like this all the time. Be

11:46

creative about how you write your policies

11:49

and procedures that give you the flexibility

11:51

to do the things you need and meet the

11:53

requirements that you have to need. Just

11:56

because something is cumbersome doesn't

11:58

make it compliant, so keeping

12:00

it simple and being creative and how you implement

12:02

that and what that looks like, guess

12:05

would be my advice to somebody in quality. Think

12:07

outside the box. I like that.

12:09

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

12:12

Yes. And then I think for any career

12:14

really, um, when you greet a great

12:16

mentor like yourself, learn all

12:18

you can from them. So I've

12:20

had some great mentors like yourself in

12:22

my career, and really just try

12:25

to learn everything you can. So you

12:27

have been instrumental to my growth here at Polio.

12:29

So I thank you for that. And for

12:32

anybody out there who comes across to Kelly in

12:34

their life, I hope they appreciate and

12:36

learn all they can from them.

12:37

Thank you. I appreciate that. It's

12:39

been really fun getting to work with you as well.

12:42

Switching around to your personal life a little bit,

12:44

what do you do for fun?

12:46

I'm based here in Colorado, so in

12:48

the winter you will find me either skiing

12:50

or sewing. I do some quilting. Um,

12:53

And then in the summer and fall, you'll find me

12:55

gardening or outside birding, hiking

12:58

and staying active. Um,

13:00

in the spring, I just kind of hide. I

13:02

don't like the spring in Colorado, the winds

13:04

are, are a little much for me. So

13:07

it is a ridiculously windy today,

13:09

isn't it? It is. wow. Colorado's

13:11

a good place to be for a skier, so that's,

13:14

uh, that's awesome. And if we found

13:16

you walking around Barnes and Noble, what

13:18

section would I find you in?

13:20

Probably in non-fiction, I

13:22

like a good biography or autobiography.

13:25

one I read recently was around Cleopatra.

13:28

Um, and it was just amazing to read

13:30

all that she was able to accomplish essentially

13:32

at my age. So, um,

13:34

she was really inspiring so, always

13:36

find it interesting to learn about other people's lives,

13:39

and what made them stronger or what made them

13:41

really committed to their, their path in

13:43

life.

13:44

That's awesome. I love that. All right,

13:47

well, where can we,

13:49

where can we find you to, to get connected

13:51

with you or keep following along with Qualio?

13:54

Tune into the podcast. I will be here

13:57

going forward hosting these, and you

13:59

can find me on LinkedIn. Um,

14:01

Meg Sinclair, you can put

14:03

my awesome, my LinkedIn in the show notes.

14:06

All right. Well, thanks a lot, Meg. I'm excited

14:08

to pass the torch your way. Thank

14:11

you.

14:11

I'm really excited to take this on and

14:13

have some great conversations with other

14:16

industry professionals.