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The FDA Group’s Nick Capman recently sat down with Marcia Baroni—VP of Enterprise GxP Compliance & Systems at Emergent BioSolutions, PDA Board member, and 25-year biopharma veteran who has led quality teams of up to 700 across five continents. From facility start-ups and product launches to $600 million remediation efforts, Marcia has made a career of turning compliance into a strategic asset.
In this conversation, she explains why most firms still treat quality as overhead, how that mindset triggered a headline-making recall, and the quick tests leaders can use to start converting “good” quality spend into brand value, resilience, and growth. Whether you’re fixing a warning letter or future-proofing operations, you’ll hear why—as Marcia puts it—“quality isn’t insurance; it’s strategy.”
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Summary, key points, and practical takeaways
Here’s a quick distillation of the discussion in case your time is short.
1. Quality is an investment, not just a cost
Marcia challenges the industry’s still-persistent framing of quality as a “cost center.” She distinguishes between:
Bad-quality costs: Scrap, recalls, deviations, and rework.
Good-quality costs: Preventive controls, testing, skilled personnel, and oversight.
While companies often try to minimize both, only one of those categories contributes to long-term value. Good-quality costs are an investment in brand, performance, and risk reduction.
“The farther you get from a warning letter, the harder it is to justify that investment. But that’s when you need it most.”
2. The pendulum problem
After major compliance events—such as FDA citations or recalls—companies tend to make significant investments in and resources for quality. But without deliberate cultural reinforcement, leadership attention often fades. The pendulum swings back toward cost-cutting, often just before the next preventable issue arises.
“There’s a lot of memory loss in the system. You feel the pain, fix it, and then start trimming again.”
3. The $600 million lesson
Marcia shares a powerful case study from her career: a nationwide OTC drug recall triggered by chemically treated pallets that contaminated product. Operators on the floor flagged that “the pallets smell funny,” but no one escalated it.
“That single gap in culture and communication led to a $600 million recall. A real quality culture would have stopped it at the dock.”
4. Culture first, metrics second
You can’t build quality on documentation alone. If employees don’t feel safe to speak up—or are punished (even subtly) for reporting issues—metrics can backfire. Marcia warns against metrics that drive underreporting instead of insight.
“If you're only tracking deviations and trying to make the number go down, you're probably just pushing problems underground.”
5. What real quality culture looks like
Marcia defines a mature quality culture as one where:
Quality is everyone’s responsibility.
QA works with operations, not above them.
Issues are surfaced early, before reaching the customer or the FDA.
Leaders model, prioritize, and consistently talk about quality.
Marcia’s recommendations for leadership
If you're unsure where your organization stands, Marcia suggests asking:
Where does quality sit on your board agenda?
Who owns it?
How often is it discussed meaningfully?
If those answers are vague, your culture may still treat quality as insurance, when it should be part of your growth strategy.
Recommended resources
Marcia suggests these resources for companies beginning the journey toward quality maturity:
Gartner Research on the cost of quality.
ISPE & PDA guidance on quality culture and maturity.
FDA publications on quality culture expectations.
“Quality demands time, money, and dedication—but it pays back in performance, sustainability, and trust. It’s not insurance. It’s strategy.” — Marcia Baroni
Marcia Baroni is a Brazilian microbiologist by training who has spent the past 27 years in the pharmaceutical and biopharmaceutical sectors, serving in nearly every quality-function role across South America, North America, Europe, and Asia. As a former site head of quality, she is known for leading culture-of-quality transformations that turn compliance from a reactive cost center into a strategic value driver.
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