Episode 16: Creating a Culture of Quality - Coleen Glessner, EVP at Emergent BioSolutions

In this insightful, candid conversation, Coleen Glessner, Executive Vice President and Chief Quality, Compliance & Risk Officer at Emergent BioSolutions, sits down with longtime friend Patty to explore what it really takes to make quality part of a company’s DNA. After discovering that lab work wasn’t for her, Coleen fell into a CRA role and went on to spend two decades at Pfizer, where a major remediation effort reshaped how she thinks about the connection between culture and quality. 

You’ll hear Coleen and Patty dig into the role of the board and C-suite in setting the tone for integrity, why aligned leadership teams can still struggle to act, and how companies can build a culture of quality without waiting for a crisis. They also tackle the forces holding back technology adoption across the industry, and what it will take to protect data integrity as AI accelerates change. This episode explores why a strong culture of quality may be the foundation that innovation in clinical research depends on. 

What you’ll hear about 

• What does a true culture of quality look like in practice? 

• How does tone at the top shape integrity throughout an organization? 

• Can companies build strong quality cultures without waiting for a crisis? 

• Where should leaders start when trying to transform company culture? 

• Why are so many organizations hesitant to adopt new technology? 

• How will AI and rapid innovation test data integrity in trials? 

This episode is intended for quality and compliance leaders, offering a clear framework for building a proactive culture of quality that supports both compliance and innovation. 

Timestamps 

00:40 – Falling into clinical trials by accident 

03:40 – Connecting quality and culture 

06:40 – The role of leadership in quality 

08:55 – Why tone at the top starts with the board 

11:30 – Why a culture of quality isn’t the norm 

13:25 – From alignment to action 

15:45 – Building quality without a burning platform 

25:15 – Where to start: measuring your culture 

28:45 – The biggest challenges facing clinical trials today 

30:50 – Why technology adoption stalls 

36:05 – Job hugging and the fear of change 

38:50 – Life beyond work 

Guest Biography 

Coleen Glessner is Executive Vice President and Chief Quality, Compliance & Risk Officer at Emergent BioSolutions, where she leads global quality, ethics and compliance, and enterprise risk management. Over a career that began as a clinical research associate and spans senior leadership roles at Pfizer and Alexion, she has become known for leading large-scale transformations and embedding quality into company culture. Passionate about integrity and accountability, Coleen also serves on the Board of Directors of Diligent Pharma.