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The FDA Group’s Nick Capman sat down with Marcus Gesner, Vice President of Global Quality at embecta, a global medtech leader in insulin delivery devices, for a wide-ranging conversation on what makes a high-performing quality organization truly exceptional.
Rather than focusing only on regulatory compliance, Marcus frames quality as both protecting a company’s “right to compete” and enabling consistent, reliable supply and commercialization.
Drawing on decades of executive leadership, including building global quality organizations under FDA scrutiny, Marcus explains how to transform quality from a cost center into a value driver, how to recruit and onboard high-performing individuals, and how to sustain a culture of accountability, innovation, and open communication.
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Marcus’s key takeaways and recommendations
If you’re short on time, here are standout insights from this episode, especially useful for quality and regulatory leaders in medtech, pharma, and beyond.
Quality is more than compliance. It’s your license to compete. Compliance is the baseline “entry fee.” High-performing organizations also ensure reliable supply, prevent manufacturing disruptions, and enable commercialization speed.
Measure outcomes, not just audits. Look beyond regulatory status to metrics like defect rates, back orders, scrap, supply chain stability, complaints, and R&D delays. Track “near misses” (holds, quality incidents) to identify process vulnerabilities before they reach patients.
Invest in quality as a business driver. High-functioning quality teams collaborate closely with R&D, operations, and commercial teams to solve problems. They reduce customer complaints, improve plant effectiveness, accelerate speed to market, and increase first-pass regulatory approvals.
Leadership and incentives matter. Organizations get what they reward. Tie variable bonuses and recognition to quality outcomes—patient safety, compliance metrics, supply reliability—not just commercial or cost targets. Positive incentives drive sustainable behavior.
Recruit for drive, courage, and creativity. Beyond technical acumen, look for candidates who lean into change, dare to tackle entrenched processes, and bring imagination to problem-solving within regulatory frameworks.
Onboarding must be structured. Develop a “landing plan” covering first-month training, stakeholder introductions, and clear expectations. Show genuine excitement and appreciation. Avoid “sink or swim” approaches—early support reflects leadership’s investment in success.
Collaboration needs intentionality. Time is the biggest barrier. Build calendars and routines that connect new hires with cross-functional stakeholders. Prioritize staff meetings that surface interdependencies, not just status reports.
Accountability requires the right tension. Set clear outcomes and maintain healthy pressure without turning reviews into “beat-up” sessions. Like tuning a guitar string, too little tension creates apathy, too much snaps morale.
Communication is the ultimate differentiator. Quality leaders must translate complex regulatory and technical issues into clear, meaningful terms for commercial colleagues and executives. Effective communication fuels influence, investment, and cultural change.
One thing to bring back to your team
Marcus recommends running a candid review of your quality organization against three questions:
Are we only meeting compliance—or also enabling speed, reliability, and commercial success?
Do our incentives, metrics, and leadership behaviors reinforce quality outcomes or actually undermine them?
Can every member of the quality team communicate simply and persuasively with non-quality stakeholders?
Running this exercise reveals whether your quality function is operating at baseline—or driving meaningful, high-performance outcomes for patients and the business.
Marcus Gesner is Vice President of Global Quality at embecta, leading all strategic and functional aspects of quality assurance worldwide. He previously served as Senior Vice President of Global Customer Quality at Olympus, Vice President of Quality at Olympus, Vice President of Supply Chain Quality at JUUL Labs, and Vice President of Post-Market Quality Assurance at Boston Scientific. He has also held consulting and leadership roles at Halloran Consulting Group, Covidien, and other firms. A former nurse, he brings both clinical and executive perspectives to building high-performing quality organizations.
Connect with him on LinkedIn here.
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