Changing the Compliance Paradigm in Large, Global Companies!

Summary

In this episode of the Executive Platforms Blueprint Podcast, Jeff Mix interviews Peter Shearstone, VP Global Quality and Regulatory Affairs at Thermo Fisher Scientific. They discuss the challenges of compliance in large global companies, the importance of quality and regulatory affairs as a leading function, and the impact of COVID-19 on accelerating change. Peter emphasizes the need for boldness in improving systems and the role of AI and machine learning in enhancing quality management.

Takeaways

• 📚 Peter Shearstone, VP Global Quality and Regulatory Affairs at Thermo Fisher Scientific, leads a team of 9,000 professionals across 140+ countries, emphasizing the importance of a comprehensive Q&RA ecosystem.
• 🌐 Peter discussed the challenges of changing compliance paradigms in large global companies, highlighting the need for efficiency and effectiveness in scaling operations.
• 🔬 The conversation covered the differences in compliance between large and small organizations, with large companies facing greater risks and a broader portfolio requiring a continuum of maturity in quality and regulatory approaches.
• 🚢 Peter used the analogy of an ocean liner and a speedboat to describe the need for large companies to adopt a more agile mindset, likening the rapid changes during the COVID-19 pandemic to the speed at which the industry needs to operate.
• 🌟 He emphasized the importance of the Quality and Regulatory Affairs function as a leading, rather than a support, function within a corporation, advocating for its central role in decision-making processes.
• 🤝 Peter stressed the need for internal and external advocacy to demonstrate the value of the Q&RA function and to drive the company towards growth.
• 💡 The discussion touched on the use of AI and machine learning to manage the vast amounts of data in the quality space, aiming to predict processes and product quality, and to automate tasks like batch record review.
• 🛠 Peter shared his belief in the importance of continuous improvement, urging individuals to challenge the status quo and to not just accept systems that are not good enough.
• 🌱 He highlighted the mission of Thermo Fisher Scientific to make the world healthier, cleaner, and safer, and the role of the Q&RA function in achieving this mission by driving growth and adding value.
• 👨‍🎓 Lastly, Peter called for engaging the younger generation, particularly STEM students, to see the value in a career in Quality and Regulatory Affairs, which is an area not well-known in universities.

Q & A

What is the primary focus of Peter Shearstone's role at ThermoFisher Scientific?

Peter Shearstone leads a comprehensive Quality and Regulatory Affairs (Q&RA) ecosystem at ThermoFisher Scientific, which includes clinical affairs, design quality, product legislative compliance, quality assurance, quality control, quality engineering, quality management, quality systems, regulatory affairs, and supplier quality.

Why did Peter choose the topic 'Changing the Compliance Paradigm in Large Global Companies' for the themed lunch discussion?

Peter chose the topic to share ThermoFisher Scientific's journey as a highly acquisitive company and to discuss how they strive to find more efficient and effective ways to manage compliance and regulatory affairs, supporting company growth without becoming a drag on the organization.

What are some differences in compliance between large global companies and smaller scale organizations according to Peter?

In large global companies, the risks are greater and multiplied over a broad portfolio, requiring a more macroscopic approach to managing quality and regulatory affairs. Smaller organizations with focused portfolios can be more specific in their compliance needs and management.

What analogy does Peter use to describe the difference between making changes in large and small companies?

Peter compares large companies to ocean liners and small companies to speedboats. He emphasizes the need to move the 'ocean liner' faster, making it easier to turn and adapt quickly, similar to the agility of a speedboat.

Who were some of the participants in Peter's themed lunch discussion, and what was their general feedback?

Participants included heads of quality from companies like AstraZeneca, GSK, and Lilly, among others. The discussion was beneficial, with feedback on ThermoFisher's journey and experiences from those who had undergone similar transformations.

What was one surprising takeaway from the lunch discussion for Peter?

Peter was surprised at how quickly some participants' companies had completed their compliance transformations and how long ago they had started, making him realize the need for ThermoFisher to expedite their own processes.

How did COVID-19 impact the speed and nature of decision-making in compliance and regulatory affairs at ThermoFisher?

COVID-19 significantly accelerated decision-making processes, with actions that would normally take months being completed in days or hours. This urgency and flexibility were driven by the need to respond quickly to the global crisis.

What does Peter believe about the role of the Quality and Regulatory Affairs function in a corporation?

Peter believes that the Quality and Regulatory Affairs function is not just a support function but a leading one. It must be at the decision-making table, as it is crucial for company success in the life sciences, pharma, and diagnostic spaces.

What advice does Peter give to those in the Quality and Regulatory Affairs field regarding advocacy?

Peter advises quality professionals to advocate for the value of their function both internally and externally. Internally, they should demonstrate the importance of being central to the organization, while externally, they should engage with professional boards and industry peers to benchmark and validate their approaches.

How is ThermoFisher leveraging technology, particularly AI, in their quality and regulatory processes?

ThermoFisher is using AI and machine learning to evaluate data, predict processes, and automate tasks like batch record reviews. This helps redeploy resources to more value-adding activities. They are also cautious, setting guardrails to ensure original thought and compliance in critical submissions.

What is Peter's final advice for those looking to change the compliance paradigm in their organizations?

Peter encourages individuals to stand up, be bold, and have the courage to challenge and improve their systems. He emphasizes not accepting the status quo and continuously striving to find better ways to enhance quality and compliance.

Outlines

00:00

🎙️ Introduction and Guest Bio

Jeff Mix introduces the podcast and his guest, Peter Shearstone, VP of Global Quality and Regulatory Affairs at Thermo Fisher Scientific. Peter oversees a large team across various aspects of quality and regulatory affairs. The discussion begins with Peter sharing his background and the theme of his recent talk on changing the compliance paradigm in large global companies.

05:01

📈 Compliance Challenges in Large Corporations

Peter discusses the challenges large corporations face in maintaining compliance and efficiency, especially as they grow through acquisitions. He emphasizes the need for a holistic approach to manage and streamline operations effectively to support company growth and avoid inefficiencies.

10:04

🏢 Differences Between Large and Small Companies

Peter highlights the differences in managing quality and regulatory affairs in large versus small companies. Large companies face greater risks and require more comprehensive systems to handle diverse portfolios. He shares insights from his experience in both environments, aiming to apply a more agile 'speedboat' mentality to Thermo Fisher's operations.

15:05

🍽️ Insights from the Themed Lunch Discussion

Peter shares insights from a themed lunch discussion he hosted, which included participants from various companies and regions. The discussion provided valuable feedback on Thermo Fisher's journey and allowed for an exchange of experiences and strategies for managing compliance in large versus small companies.

20:05

💡 Lessons from the Pandemic

Peter reflects on the accelerated pace of decision-making and problem-solving during the COVID-19 pandemic. He emphasizes the importance of maintaining that intensity and agility post-pandemic to tackle complex challenges efficiently and effectively.

🌐 Advocating for Quality and Regulatory Functions

Peter underscores the importance of the quality and regulatory functions in a corporation, advocating for their role as essential partners in decision-making. He encourages leaders in these functions to champion their value and engage in both internal and external advocacy to drive improvements and growth.

🤖 Leveraging Technology and AI

Peter discusses how Thermo Fisher is leveraging AI and machine learning to improve quality and regulatory processes. He highlights the importance of governance and careful implementation of these technologies to enhance efficiency and redeploy resources for greater value creation.

🔍 Encouraging Bold Changes and Continuous Improvement

Peter advises individuals in the life sciences to be bold and proactive in challenging the status quo and driving improvements in compliance systems. He emphasizes the importance of continuous improvement and active engagement in identifying and implementing better ways to work.

🏆 Final Thoughts and Call to Action

In closing, Peter reflects on the mission of Thermo Fisher to make the world healthier, cleaner, and safer. He encourages future generations to join the quality and regulatory fields, highlighting the critical role these functions play in the success of the company and the industry.

Keywords

💡Executive Platform

An 'Executive Platform' is a term that likely refers to a high-level professional setting or forum where leaders in a particular industry gather to discuss and share insights. In the context of the video, it is the environment in which the podcast series is hosted, and it is where Jeff, the head of content and research, interacts with guests like Peter Shearstone.

💡Quality and Regulatory Affairs

This term encompasses the functions within an organization that ensure products and services meet required standards and comply with regulations. In the video, Peter Shearstone is the VP of Global Quality and Regulatory Affairs for Thermo Fisher Scientific, leading a team responsible for maintaining the company's compliance and quality across its global operations.

💡Thermo Fisher Scientific

Thermo Fisher Scientific is a multinational biotechnology product development company known for its wide range of products and services in the life sciences industry. In the script, Peter Shearstone discusses his role and the company's approach to quality and regulatory compliance, emphasizing the importance of this function in supporting the company's growth and operations.

💡Compliance Paradigm

The 'compliance paradigm' refers to the established methods, practices, and principles that govern how an organization ensures it meets regulatory requirements. In the video, Peter discusses changing this paradigm in large global companies, suggesting a need for more efficient and effective approaches to compliance.

💡Acquisitive Company

An 'acquisitive company' is one that grows through the acquisition of other businesses. The script mentions that Thermo Fisher Scientific is a highly acquisitive company, which has implications for how it manages quality and regulatory affairs across its diverse and expanding portfolio.

💡Risk Maturity

Risk maturity in the context of the video refers to the level of risk associated with different products or processes within a company's portfolio. Peter discusses the need for a system that can accommodate varying levels of risk maturity, from less risky products to those with higher stakes, such as drugs for human consumption.

💡Change Management

Change management is the process of transitioning individuals, teams, and organizations from a current state to a desired future state. In the script, Peter talks about the challenges of change management in large organizations, using the analogy of moving an ocean liner versus a speedboat to illustrate the need for agility and speed in implementing changes.

💡Advocacy for Quality

Advocacy for quality involves actively promoting and supporting the importance of quality within an organization. The video script highlights the need for leaders in quality and regulatory affairs to advocate for their function as a leading, rather than a support, function within the company.

💡Artificial Intelligence (AI)

Artificial intelligence refers to the simulation of human intelligence in machines that are programmed to think like humans and mimic their actions. In the video, Peter discusses the use of AI and machine learning in quality and regulatory affairs to manage large volumes of data and improve processes.

💡Continuous Improvement

Continuous improvement is a philosophy of constantly seeking to improve products, services, and processes. In the script, Peter mentions a tool called PPI (Practical Process Improvement), which embodies the company's commitment to ongoing enhancement and the expectation for employees to identify and address areas for improvement.

💡Covid-19

Covid-19 is the disease caused by the novel coronavirus SARS-CoV-2. The pandemic has had a profound impact on businesses and societies worldwide. In the video, Peter reflects on the rapid changes and adaptations made during the Covid-19 crisis, using these experiences to inform the company's approach to agility and responsiveness.

Highlights

Peter Shearstone, VP Global Quality and Regulatory Affairs for Thermo Fisher Scientific, leads a team of 9,000 professionals across more than 140 countries.

Thermo Fisher Scientific's quality and regulatory ecosystem includes clinical affairs, design quality, product legislative compliance, and more.

Peter's career spans nearly 35 years with executive roles in healthcare and life sciences industries.

The discussion at the Pharma Manufacturing World Summit focused on changing compliance paradigms in large global companies.

Large corporations often expand without holistically reviewing additions, leading to inefficiencies.

Thermo Fisher Scientific is a highly acquisitive company, aiming to improve efficiency and effectiveness in quality and regulatory affairs.

Risks in large companies are multiplied over a diverse portfolio, requiring a continuum of maturity in quality and compliance.

Peter emphasizes the need for a culture and system that can accommodate differences in risk and maturity across a broad portfolio.

Large companies have the resources and competencies that smaller firms may lack, but change can be slower.

Peter aims to bring a speedboat mentality to Thermo Fisher Scientific, making the company more agile and responsive.

The lunch discussion included participants from various geographies, offering diverse perspectives on compliance in large companies.

Participants shared their journeys and feedback on changing compliance paradigms, providing valuable insights.

Peter learned from the discussion that some companies had started their transformation 5-10 years ago, highlighting the need for urgency in change.

The COVID-19 pandemic demonstrated the potential for rapid change and agility in response to disruption.

Peter advocates for maintaining the intensity and commitment seen during COVID-19 in the pursuit of change and improvement.

The quality and regulatory organization is crucial and should be a leading function in any corporation.

Leaders in quality and regulatory affairs must advocate for their function's value and be champions of opportunity creation.

Peter emphasizes the importance of both internal and external advocacy for quality and regulatory affairs.

Artificial intelligence and machine learning are being leveraged to handle vast amounts of data and improve quality processes.

Thermo Fisher Scientific is exploring the use of AI to predict processes, improve product quality, and automate batch record reviews.

Peter advises those in life sciences to be bold, challenge the status quo, and continuously strive for improvement.

Thermo Fisher Scientific's mission is to make the world healthier, cleaner, and safer, with quality and regulatory affairs playing a key role.

Peter encourages engaging younger generations in quality and regulatory affairs, highlighting the need for fresh perspectives and talent.

Transcripts

[Music]

hello again everyone you're listening to

another episode of executive platforms

blueprint podcast series my name is Jeff

mix I'm executive platform's head of

content and research my guest today is

Peter shearstone the VP Global quality

and Regulatory Affairs for thermofisher

scientific Peter leads a team of

approximately 9,000 quality and

Regulatory Affairs professionals at the

Enterprise level as well as in

thermofisher Scientifics many businesses

and operations spanning more than 140

countries Peter leads a comprehensive q

and ra ecosystem that includes that

includes clinical Affairs design quality

product legislative compliance quality

assurance quality control quality

engineering quality management Quality

Systems Regulatory Affairs and supplier

quality prior to joining thermofisher

Peter held executive quality and

Regulatory roles with companies in the

healthcare and Life Sciences Industries

over the course of a career spanning

nearly 35 years Peter thank you so much

for joining me today thanks Jeff really

appreciate the time and the opportunity

it's good to meet you as well you hosted

a themed lunch discussion at our Pharma

manufacturing World Summit in Boston

entitled changing the compliance

Paradigm in large global companies you

know having just read some of your bio I

think I can guess at some of the answer

but what made you choose that topic

specifically well you know Jee I think

the

um you know large corporations you know

are established at some point in time

and they grow and they expand whether

it's through organic or inorganic means

right and oftentimes the company just

just adds and doesn't look at those

additions

holistically and think I could do it a

different way or I could be more

efficient and more effective and so my

my thought process kind of going into

the session that lunch session was kind

of sharing the journey that we've been

on as a highly acquisitive company um to

to find a better way you know to do it

that's more efficient more effective and

that at the end of the day you know

leads to a a quality and Regulatory

Affairs function that can again be

maximally efficient to support the

growth of the company um if you're all

you're doing is adding and not taking

anything away well you're not you're not

being able to scale and you're actually

putting a drag on the organization so

that was really the intent of of doing

that talk when you think about

compliance at large global companies

versus smaller scale organizations what

are some of the biggest differences you

want to highlight for

listeners so I think you know with a

large scale company the the risks are

greater right they're multiplied over

the portfolio so at thermofisher you

know we make everything from electron

microscopes to contract drug

manufacturing clinical research uh

ivds um chemicals Plastics you know the

the range of our portfolio is is pretty

immense and um when you think about

quality and Regulatory across that space

it's a Continuum of maturity you know

some of the less risky less comp complex

products are going to need you know a

different level of quality and

compliance if you will then then you're

making a drug for human consumption

right so to me it's being able to span

that portfolio with a culture and a

system and processes that can

accommodate that difference in risk and

that R difference in maturity that you

wouldn't necessarily have actually in a

smaller firm where you've got a smaller

portfolio very focused portfolio where

you know you know the risks and

limitations of that you know particular

segment that you're in if it's an ivd

for example you know you can carve out

and be more focused with us we've got to

be a little bit more macroscopic in our

thinking

now in your career you've worked in a

few different groups is there something

from your experience working at larger

versus smaller companies that you could

share to illustrate some of what you're

talking about so you know certainly the

large company uh model is going to have

the ability uh resources competencies

that that you may not have at at a

smaller firm that said the larger the

change at a larger firm obviously takes

a long time as a longer period of time

right so it's really comparing you know

uh a cruise liner you know to a

speedboat in many cases and having

worked in both

environments um I'm what I'm trying to

do at thermofisher is take that

speedboat mentality kind of that covid

time mentality when we were going

through a lot of different things

happening all at once you know as a as a

as a as a globe as a world um and move

that that ocean liner faster make it

easier to turn make it easier to back up

if we have to I hope I hope the analogy

flies because for us it's it's we we

can't keep being the ocean liner we

we've got to be a speedboat with these

9,000 folks that are in the function and

again find a much faster more efficient

way to to get ahead for our customers

and our shareholders returning to the

themed lunch discussion you hosted I

want to give listeners a little context

um these lunches are some of the most

popular content we build into our Summit

agendas because each one is a 1hour

small group interaction that up to 10

people can opt into from a list of

options you know so it's a meal with

like-minded people talking about

something they all chose ahead of time

and the only downside is by its very

nature the takeaways tend to stay in

that small group which is what I'm

hoping we can get into in the next few

questions let's start off by talking a

little about who joined your lunch now

you don't have to name any names of

course but was it the sort of job titles

and companies you were expecting uh did

anyone surprise you by choosing to take

part in your topic there were no

surprises per se um you know we had we

had the head of quality for as zenica at

my table we had um GSK and and um Lily

and other companies that but honestly

are customers of ours so uh and then we

had other folks that were I think just

interested in the topic you know that

were not from um our customer base

you're not from the the let's say the

the C cdmo world that joined as well so

it was a good blend of of folk that that

came to the discussion um you know it

was was uh it was eye openening I have

to say we had we had folks from the US

we had folks from Europe folks from

Japan actually um and so being able to

see the differences in you know

geographies how things are done um kind

of sharing again again with the lunch

topic the large versus the small or how

to move you know differently in the uh

in the compliance space for a large

company it was it was really uh

beneficial I really enjoyed it now

you've already told us some of your

thoughts on this subject how did

resonate with the group lot of

discussion some of them had already been

through it actually so for me it was

presenting our our journey but also

getting feedback on that Journey from

people that already done it you know so

so and that's what I hope to get out of

that discussion was that it was a back

and it wasn't just me sitting there you

know spouting for an hour it was it was

hey this is what I this is what we've

done this is the journey we're on give

me feedback you know if I can teach you

something that we did and you can find

that beneficial great but tell me am I

doing the right thing am I is the

speedboat Cruise liner analogy does that

make sense to you and have you faced the

same thing you know have you faced that

that challenge of of change management

where you're trying to again move an

organization in a particular

direction over a defined period of time

um is that the right period of time is

it the right approach should we do

smaller chunks versus bigger chunks so I

think that was the real benefit of of

the lunch meeting was being able to get

that feedback and know and calibrate

know where we were headed and it was the

right thing to do now of course you

picked the topic and you live and

breathe this stuff in your day-to-day

work did anyone say anything you did not

expect to hear is there something new

that you took away from the conversation

well I I think back to it was the shared

experience that others have you know

have done in this space large and small

you know I will say this there was

wasn't just companies that were there

there were some smaller firms as well um

so it was good to hear things from from

that

perspective um there were no there were

no surprises really um just just that I

think the ones that had already done it

I think maybe if there was a surprise it

was how fast they actually had had done

it and how long ago they had started so

for some of the customers of ours you

know they had gone through this 5 10 15

years ago and um so for me it was you

know again the appreciation for the fact

that they had done it and when they had

done it so I'm I'm kind of looking in

the mirror thinking okay uh we need to

we need to get on the horse here and go

faster um and be a lot more thorough

than than perhaps we were planning to to

be I'd like to follow up on that a

little bit because you were mentioning

earlier how covid sort of changed the

way things are done and your

transformation is is being informed by

some of that experience and here there

were people at your table who they

started their transformation 5 or 10

years ago so that would have been before

Co did you see a big difference in how

they were telling their story the people

who were doing it before covid versus

the people who were doing it after covid

yeah there was there were definitely

differences I you know I can't you know

put my my finger on the pulse of the of

the major differences other other than

the speed at which things were happening

you know during covid you know a day was

a week a week was a month a month was a

year you know an hour was a day I mean

we were moving so quickly making so many

decisions uh with such velocity and

intensity

um

that you know we needed to go and rent a

warehouse to store tests to help test

people you know we were making that deal

in a day you know and normally that

would take in a in in in non-co time

that would take six months um you know

we were able to get reimbursement for

our covid test um in I think eight hours

in some of the countries that that we

worked in where normally in that country

it's a 9 to 12 month period of time

right so so we found this amazing

flexibility and intensity with with not

only internally but externally as well

to get this work done to save Humanity

right and I I often think Jeff that if

we had that same level of

intensity and

passion postco and and to your question

even preco how different would would we

be as a company you know I so I'm what

I'm trying to do back to my analogy of

an ocean liner and a speedboat is is

trying to bring that level of intensity

energy commitment to um to our efforts

to

change with a with respect to how we did

things during Co and I think during the

during the lunch discussion it was it

was generally agreed that all of us wish

we could take that that passion that

intensity that we had during those those

few years 2020 through let's say

2022 and mobilize it you know this the

same way we mobilized it then to solve

some of our most most you know tricky

problems that we have um today example

having a really complex quality

management system so that that really

resonates with me and it echoes a lot of

what I'm hearing from other people um I

think one of the things that the

pandemic really did was show us what was

possible that we can move faster that we

can be more agile and responsive in a a

time of just constant disruption so I I

really appreciate you making that point

um returning returning to the lunch

because I appreciate it wasn't just you

know telling War Stories from covid-19

you know what do you hope other people

got from the lunch discussion that we

can share with our listeners well I I

think that the quality and Regulatory

organization number one is a super

important part of any Corporation it's

it's not a support function it's a

leading function has to be a leading

function we have to be at the table

where decisions are being made uh

because at the end of the day the

companies run in in this space life

science Pharma device diagnostic space

companies run and succeed because they

have quality and Regulatory Affairs

working behind the scenes to get

products registered to keep the quality

system clean to stay compliant to have a

good culture right so I I I really

wanted the the folks at the lunch to

understand that that don't

accept that the quality and Regulatory

Affairs function is is not a partner is

not valuable it absolutely is a partner

it absolutely is valuable and we as the

leaders in the function have to be

carrying that flag we have to carry that

flag and plant it and say look we're

here we can help you that's how I that's

how I really came away from our from our

lunch

discussion I wonder if we can expand

upon that a little because I know so

many people in the quality space who you

know 100% what they do is vital to the

function of their organization but it

can sometimes feel there's a a quality

team and there's everybody else and of

course getting what you need what you

want the the resources the attention the

the the decision-making speed as you

were talking about there's a lot of

things you need from other people inside

and outside an organization I guess what

I'm asking for is can we talk a little

bit about advocacy for

Quality yeah I think I think that's a

great question Jee and and I really

appreciate that you know

the the function sits to me at at the

center of the wheel and every other

function Finance HR operation supply

chain R&D

commercial everybody has to run through

the quality regulatory function and

internally I think as the leader of the

function if you if someone out there

listening is the leader of the

function you've got to advocate for the

value of being at that that center of

the Hub you've got to be a champion of

of creating opportunity and value

creation for all of those other

functions right to drive the company

towards growth also I think you got to

spend just as much time externally so I

think you've got to spend time on on a

on a professional Board of some kind

where you're with um peers maybe it's

with the American Society for quality

for example or maybe it's WS which is

the Regulatory Affairs professional

Society maybe you're involved there

where you can engage and have

conversations with people that are you

know in your

shoes if anything as I said to my early

remarks to Benchmark kind of what you're

working on in a in a in a safe place

with you know no risk of confidentiality

but in a safe place say am I doing the

right things am I focused on the right

things and again that exchange of

information externally actually helps

power your internal advocacy efforts

quite honestly because if you can if you

can have an argument internally and say

well I think this is the way it should

be done people might not listen but if

you say well this is the way it should

be done and by the way it's the same way

BR and gamble or J&J or whoever else

does it um it comes with a different it

hits with a different intensity it hits

with a different Power I think so I

really I really think that internal and

external advocacy is essential for the

roles like like mine um you know in the

in the quality R

function I almost feel like I can't do

an interview these days without talking

about how technology is changing the

conversation um maybe even a

specifically artificial intelligence but

you know broadly speaking I think

quality more than most is a discipline

that is leveraging these new tools that

is looking at their options that already

is dealing with a just a waterfall of

data more than any one person could ever

get their arms around there have to be

tools to help them do their job better

um I know we're starting to run out of

time here but I I would love uh some of

your thoughts in in that topic area if

we can yeah I mean look Ai and and

machine learning large language models

you know all that um has definitely

helped us um we're in the um you know on

that on that Journey you know we've

established governance teams we've

established a process we've established

a user case use case evaluation tool U

we've we're working with our it Partners

internally to use chat GPT and then the

next version which I think is 4.0 to to

find ways to evaluate as you said all

the data that we have available whether

it's Kappa data complaint data even

inprocess data from manufacturing how do

we utilize these tools to predict

processes to predict product quality to

avoid having to do maybe uh um you know

an additional step in the process or

even maybe to automate batch record

review and and and by the way take those

resources that are actually current

doing that work and focus them on the

next generation of of AI right so not

necessarily eliminating positions but

finding a way to redeploy those folk to

help create more value for the company

and I can take someone off the line for

example that's a highly experienced

quality person and I can put put them in

in inside the the corporate team here

and do internal auditing of

manufacturing spaces well that's a

win-win win you know automation wins the

person wins and the function in the

company wins so you know to me uh Jeff

that's that's how I see it playing out

um I will say you know there are guard

rails that we've put up right so you

know when it comes to let's say 510k

submissions to the FDA or pre-market

submissions to the to the FDA you know

those require a lot of original thought

right so 's got to sit down and put the

pieces together in the right way in

order for the FDA to to to see it and

and um and obviously clear it you know

at some point um and if it's a Kappa for

example you really want to show your

process it's kind of like in school you

want to show your work um so I think

there's this for us we've put some some

limitations in place and um yeah that's

how it's uh it's played out for us it's

been it's it's an exciting time

absolutely um we are coming up towards

the end of this uh this time we've set

aside what advice do you have for people

working in the Life Sciences who want to

help change the compliance Paradigm in

their organizations what should we be

thinking about and learning about

further well I think I think Jeff people

got to stand up and be bold and have the

courage to look at their systems and say

it isn't good enough you know it's not

what we need um we got to find a better

way every day I think that's that's what

I tell my team all the time you you if

something isn't right

do something about it don't just accept

the status quo um I think it's the I

think it's the U TSA or Department of

Homeland Security right see something

say something right don't don't just

live in the system and woe is me it

you've gotta take and and engage in

trying to make a difference and I tell

that to you know folks all the way down

to the to the to the tech level you know

you've got to find a way to stand up and

say this isn't right and then improve it

you know our internal Improvement um

continuous improvement tool is called is

called PPI it's practical process

Improvement it's our business system and

that's what's expected when you come to

our company you you see something you've

got to change it so I would tell

everybody out there don't just accept it

fix it change it challenge it speak up

um because I think the reputation of

quality and Regulatory sometimes is we

just sit on the sideline can't sit on

the

sideline that's a phenomenal Point um I

do maybe want to do one more with you I

mean it's such a big topic and I feel

like I could talk to you all day about

this but again of course I want to be

respectful of your time just before I

let you go is there anything you want to

say as a way to close out the interview

well Jeff firstly really thanks for the

opportunity number one uh it's been a

tremendous um my first podcast ever so

really appreciate the time oh my

goodness I had no you're a natural yeah

well I appreciate that very much but uh

you embarrass me a little bit um look

you know thermofisher operates in as you

said hundreds of countries uh we make an

impact to our customers every day right

we our mission is to make the world

healthier cleaner and safer uh we

believe in that mission the work that we

do um today and and I've been here six

years now um is all around that right

and and in order to make that happen as

as I said the function has to stand up

and and carry that flag and say you know

we're here to help we can make a

difference um we can add value and we

can drive growth you know it's not just

about Audits and and compliance it's

about you know how do we get products on

the market faster how do we get customer

complaints resolved quicker how do we

get um our our employees developed and

onto to their next part of their career

within the function you know those are

things that that I'm super passionate

about and I think lastly how do we get

students in universities all over the

world that are either science or or

let's say stem students how do we get

them to see the world that we live in

and come and be a part of it because we

really really need to get um I think the

younger Generations you know into

quality and Regulatory Affairs because

honestly it's an area that they don't

know that a lot of the universities

don't know about and we've got to help

them see that what a great note to end

on Peter thank you again so much for

your time it's been a pleasure Jeff

fantastic uh best to you and uh have a

great day absolutely you've been

listening to another episode of

executive platforms blueprint podcast

series I've been Jeff mix let's do it

again soon