It’s World Quality Month, and for those of us in Quality, it’s an interesting annual event. Our work, if we’re doing it well, is meant to be invisible. When we do our jobs perfectly, nothing happens. No headlines, no drama. It’s a strange thing to celebrate: the absence of catastrophe. After more than 36 years in this field, I have come to truly appreciate that.
My career began in a medical laboratory, a world of measurements and tangible outcomes. The link between my work and a patient’s well-being was direct and unambiguous. I miss the definitive answers from the lab, but I don’t miss having to diplomatically present them to certain physicians who thought their hunches outweighed the data.
As I moved into pharmaceuticals and medical devices, the scale of my responsibilities expanded, but the core principle remained the same. I just had to build systems that could replicate that lab-level care across global organizations. As I moved from the lab into corporate quality, I realized my job was less about enforcing rules and more about being a translator. I had to move out of my “Quality Bubble” and move into “Business-speak”. I’d sit in meetings where the engineers wanted to move fast and the commercial team wanted to break things. My job was to gently (and sometimes not-so-gently) remind everyone that while speed to market is great, speed to a Warning Letter is considerably less fun.
My move into executive leadership was learning that the bigger the title, the more time you spend in meetings about meetings. But it was also where I saw the true power of quality. A well-built Quality Management System isn’t a cage; it’s the guardrails on a winding mountain road. It doesn’t slow you down—it lets you drive faster with the confidence you won’t plummet off a cliff. Leading teams through post-merger integrations and global system rollouts taught me that you can have the most beautiful SOP ever written. Still, if your people don’t understand it, it’s just very expensive origami.
I’ve spent decades as what I call a “professional skeptic.” During executive meetings, I might take the opportunity to say, “I appreciate the business case, but what about possible issues?” While usually not met with enthusiasm, I believe wholeheartedly in presenting quality as a strategic advantage rather than treating it as just being compliant. It’s a challenge I truly love! I’ve learned that convincing a room of goal-oriented people that the right path is sometimes a slower one requires less authority and more diplomacy, and a little bit of sales. It’s about building a case, not just citing a regulation.
After 30 years, I jumped the corporate fence and became a consultant. If you ever want a class in humility, try telling a cash-strapped startup founder that they need to slow down and document their design controls. It’s like telling a toddler on a sugar high to please meditate. This role gave me a different perspective, and I can confirm two universal truths: 1) Everyone struggles with supplier management, and 2) No one, and I mean no one, has ever said, “Our CAPA system is running perfectly!”
Consulting offers a broad view of the industry’s challenges, from startups fueled by passion but running on fumes to established giants tangled in their own legacy systems. The patterns are interesting. The struggle to implement a practical, risk-based approach is universal. I’ve lost count of the times I’ve reviewed a “robust” procedure that, in practice, was a work of fiction, used, it seems, purely for auditors.
These days, a huge part of my joy comes from teaching, a role that has synthesized the most enduring part of this journey: the shift from building systems to building people. I try to impart to the next generation that knowing 21 CFR 820 or 211 is just table stakes. The real magic, and the much harder lesson, is in the art of influence. We can teach the CFRs and ISO standards; the real curriculum is how to tell a VP their favorite project is non-compliant without giving them an aneurysm, how to coach a terrified team through a regulatory inspection without anyone hiding in the bathroom, and how to make a tough, risk-based decision when every option carries some form of consequence. It’s about holding your ground, not with a hammer, but with a calm, unshakable demeanor.
A different, but equally profound, satisfaction comes from a legacy that spans my entire career: watching my former team members and long-time mentees flourish. These are professionals I worked with years, even decades, ago in my corporate roles, and seeing them now as strong, quality-led leaders in their own right is a unique point of pride. They are the ones now championing robust systems and mentoring the next generation, creating a ripple effect that extends the impact of our work far beyond any single project or organization.
The tools have changed, we worry about data integrity in the cloud now, rather than paper notebooks, but the mission hasn’t. We’re navigating AI in medical devices, and global regulatory shifts every day, it seems. We are the patient’s advocate in a room full of competing priorities. We are the ones who ask, “Yes, but what if…?” while everyone else is high-fiving.
This World Quality Month, I’m not celebrating binders of procedures or a clean audit. I’m celebrating the competence, the intellectual rigor, and the sometimes stubbornness required to do this job well. To all of you who spend your days in the details, who write the reports few will ever read to ensure outcomes everyone depends on: I see you. Your work, though designed to be invisible, is essential. And that is genuinely worth noting.
Jackie Torfin has held leadership roles across the medical device and pharmaceutical industries and now spends her time consulting and teaching, dedicated to the notion that good systems require great people to make them work.