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Your quality system might pass inspection, but what about your culture?
The FDA Group’s Nick Capman sat down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality culture that drives compliance, operational excellence, and long-term resilience in the biopharma space.
With regulatory expectations often moving faster than organizations can restructure, “quality culture” has become more than a buzzword. It’s the differentiator between teams that react to issues and those that prevent them in the first place. A strong quality culture aligns every level of an organization around doing things right the first time, making decisions rooted in science and ethics, and viewing compliance as an enabler of performance rather than a constraint.
Chris is a microbiologist by training with more than 35 years of biopharma leadership experience, and has lived that transformation firsthand. He’s led global quality organizations at Ipsen, Cubist (Merck), and now Tolmar, as well as his own consultancy. Across the U.S., Europe, and Asia, he has managed large CMO networks, overseen inspection-readiness programs, and led cultural change within complex, matrixed organizations.
This discussion explores what truly defines a quality culture today, how leadership behaviors and incentives shape it, the practical steps to embed it across global operations, and why sustaining it requires consistency, humility, and clarity of purpose.
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Chris’s key insights and recommendations
If you’re short on time, here are standout lessons from the episode:
Define your culture simply—and actually live it. A quality-driven culture means employees see, hear, and feel quality everywhere in their jobs. It’s about doing things right the first time, where patient safety and compliance take priority over short-term financial performance. Chris helped co-author PDA Standard 06-2025, Assessment of Quality Culture, which offers practical tools and models for evaluating and improving culture—a useful starting point for any organization seeking to measure progress objectively.
Align your values with behavior. Values like patient centricity or doing things right the first time only matter if they’re actually actioned. Organizations must reward and recognize behaviors that reinforce those values, and hold people accountable when they don’t. A culture of excellence can’t coexist with complacency, politics, or fear.
Leadership always sets the tone. Executives create culture through what they tolerate and reward. If leadership prizes profit over integrity, that mindset cascades downward. Conversely, when CEOs and senior leaders consistently model quality and compliance, recognize good behaviors, and make patient safety visible in every decision, the organization mirrors that example.
Manage pressure and uncertainty with focus. Drawing on lessons from Navy SEAL training and neuroscience, Chris describes how leaders can maintain calm under pressure: fear arises from uncertainty + anxiety. Using breathing, visualization, and clear priorities can help prevent “amygdala hijack” during stressful periods like inspections or remediation. Keeping personal visual reminders of values and goals builds mental resilience and focus amid competing demands.
Changing culture takes time—three to five years on average. Transforming an organization’s mindset is a multi-year effort that depends on leadership consistency, removal of toxic behaviors, and reinforcement of desired values. Even after leadership changes, remnants of old habits can persist; shifting culture requires patience, collaboration, and persistence.
Return on investment matters, but ROI isn’t only financial. Quality initiatives must show value—through improved compliance, efficiency, or waste reduction. Lean and Six Sigma methods help eliminate non-value-added work so teams can focus on risk management and patient safety. Chris cautions: it’s far cheaper to invest proactively than to face a $500 million consent decree after a compliance failure.
Measure what matters. Use established frameworks like the PDA Quality Culture Survey or Gartner’s benchmarking tools rather than reinventing metrics. These resources help companies quantify cultural progress, identify gaps, and demonstrate measurable improvement over time.
Shift from reactive to proactive. Chris describes turning a post-inspection remediation program into an Inspection Readiness Steering Committee—maintaining the same cadence and rigor, but with a proactive mindset. By continuously monitoring risks, engaging external experts for mock inspections, and addressing gaps before regulators find them, the organization stayed inspection-ready year-round.
Overcome obstacles with alignment and clarity. Common barriers like limited budgets, leadership skepticism, or misaligned teams require clarity of purpose. Leaders must start with “why,” as Simon Sinek advises, to win support across the organization. Shared purpose unites people behind the transformation.
Continuous improvement never ends. “There’s no finish line,” Chris says.
Complacency is the enemy of quality. Even companies with perfect inspection histories must keep learning and challenging themselves. When leaders and teams embrace imperfection as fuel for growth, they stay resilient and compliant.
One thing to bring back to your team
Conduct a quality-culture assessment using PDA Standard 06-2025. Map where your organization truly stands today, identify 2–3 behaviors that contradict your stated values, and create one visible recognition program that rewards the right actions in real time. Culture changes through consistency, not campaigns.
Chris Masterson is Senior Vice President of Quality and Chief Quality Officer at Tolmar, where he leads global Quality Assurance, Quality Control, and Quality Systems operations across manufacturing and R&D. A microbiologist by training, he is a recognized expert in contamination control, aseptic processing, and inspection readiness, with prior executive roles at Ipsen and Cubist Pharmaceuticals (Merck). He has managed global quality functions across GxP areas (GMP, GDP, GLP, GCP, GVP), overseen large CMO networks, and driven leadership development and culture change throughout his career.
Connect with him on LinkedIn here.
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