How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson

Hello, everyone. Welcome to the Life Science Rundown. This is Nicholas Catman with the FDA group. Before we jump into our discussion for today, just a little bit about the FDA group. We help life science companies in the areas of quality assurance, regulatory affairs, clinical operations, commissioning, qualification, and validation, as well as pharmacovigilance. We offer three different engagement models, which are consulting, staff augmentation, and full time employer recruitment. So if you're finding yourself in need, just head over to the fdagroup.com to check us out and get in touch. So today, I'm speaking with Chris Masterson. Hey, Chris. Hey, Nicholas. How are you doing today? I'm doing great. Thank you for joining me today. Thank you. Okay. Before we jump into our topic, would you kindly introduce yourself? Yeah. So my name is Chris Masterson. I am the senior vice president and chief quality officer for Tomar. I've worked in the biopharmaceutical industry for the last, let's see, thirty six years. Started in 1989, way before some of you were born likely, and married, have two children, two beautiful children, care about everybody. And I'm a I'm almost 60 years old now, and I'm on the, the twilight of my career. What I'm trying to do now is really better develop the talent for the future, of biopharmaceuticals. Okay. Well, that's a great, sequitur into the topic. So our topic for today is how can biopharmaceutical organizations build and maintain a strong quality culture accounting for time, leadership support, measurable results, key skills, and the internal and external factors that drive or hinder success. So there's a a lot to uncover there. Why don't we start here? So how would you define a quality driven culture, and why is it essential for long term success? Yeah. I'll start with my definition of culture, and then I'll get into the definition of what other people think. Okay. So my definition of culture is the way things are done around here. You know, some companies that I've worked with are very family oriented. Some are authoritarian. Some are friendly. Some are accountable, hardworking, driven, fun, etcetera. I think that the way things are done around here is what I define as culture. The dictionary defines it a little differently. They say the shared values, attitudes, and practices, that characterize an organization and influence how its members behave and interact. I would say quality driven is about how people perceive doing things right the first time. In pharmaceuticals, quality is typically about GXP compliance where GXP equals, the x is algebraic, and it equals good manufacturing practices, good clinical practices, good distribution practices, etcetera. And it's about g x GXP compliance. It's really not about quality. Quality originally as defined was really Deming, Duran, Crosby, and all about operational excellence, lean six sigma, that sort of thing. But in the pharmaceutical industry, it's more about, the the compliance of the organization, the biopharmaceutical organization. So I recently helped, write a …