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.