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Many life science companies treat inspections more or less like exams. There’s a date on the calendar (or there might be, or there might not be), and at some point before it arrives, a quiet scramble begins. “Pull the documents.” “Prep the SMEs.” “Start cleaning up the backlog.”
The problem with that approach isn’t that it can fail spectacularly. It’s that it works just well enough to reinforce the habit. Until one day, of course, it doesn’t.
Nick Capman recently sat down with Yeime Martich, Vice President of Quality Assurance at TerSera Therapeutics, to talk about what it looks like when inspection readiness stops being a periodic exercise and becomes the way a company actually operates.
Yeime has spent 25 years in pharma and medical device quality systems. She’s a computer system engineer by training who has dedicated her entire career to compliance, quality system design, and inspection readiness. Before TerSera, she spent over 11 years at Hospira in global compliance roles (building internal audit programs across manufacturing sites in the US, Canada, Europe, India, and Australia) and held quality systems leadership positions at Melinta Therapeutics and Abbott.
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Yeime's key insights and practical takeaways
If you're short on time, here are the most important lessons from the discussion.
Companies treat inspections as events when they should treat them as the natural output of a healthy quality system. The instinct to prepare for an inspection weeks in advance is a symptom. If your processes, systems, and procedures are functioning the way they should, and if the people who present during inspections understand what they do and why, readiness isn’t something you “build.” It’s something you should already have. When organizations treat readiness strategically, they design systems that are always in a state of control.
Inspection readiness as a competitive advantage looks like confidence and speed, not perfection. You don’t need to have everything at 100%. You need to be able to confidently present the activities you do every day. Yeime uses the phrase “minimally compliant” not as a shortcut, but as a discipline. Understand the requirement and the intention behind it. Then meet it. Add the bells and whistles later. The danger is building procedures that look impressive on paper but are impossible to follow in practice. That’s where companies get dinged: not for lacking procedures, but for not following the ones they wrote.
Overcommitting in your procedures creates risk that doesn’t need to exist. If your deviation procedure says you can’t release a product until every associated CAPA is closed, you’ve built a bottleneck into your system that the regulation doesn’t require. You could define that CAPAs unrelated to product disposition don’t block release. But if your procedure says otherwise, an auditor will hold you to what you wrote. Yeime has seen this across organizations. Companies are adding requirements beyond what the regulation asks for, then being judged against their own inflated standard.
A well-designed QMS doesn’t slow the business. It gives the business the tools to move. Quality should be at the table with options, not blocking the door saying no to everything. When the quality organization functions as an enabler, business integrations accelerate: vendor selection moves faster, geographic expansion becomes manageable because you can handle multiple regulatory frameworks, and risk-based decisions happen in real time rather than in committee after committee. That only works when the QMS is flexible enough to accommodate new products, new regulations, and new requirements without major disruption.
Leadership shapes quality culture through three things: what they ask about, what they fund, and what they tolerate. If leadership asks for metrics on how quickly deviations close rather than whether investigations are thorough and CAPAs prevent recurrence, that tells the organization what matters. If they restrict resources for quality because they’re allocating to sales, that tells the organization what matters. And if quality keeps raising risks and leadership ignores them, that tells the organization what matters. Senior leadership has a responsibility to signal that quality is not just a compliance function but an enabler of sales and operations. But Yeime is clear that the responsibility runs both ways: the quality organization needs to present the facts, explain the impact, and make the case for why their decisions matter. If you can’t release a product, you can’t have sales. That’s the argument.
The “quality as police” perception is quality’s problem to solve. Yeime doesn’t put this on the business. She puts it on the quality organization to do better at explaining the why. Why something can or can’t be done. What the risk is. What the mitigations are. What happens if you skip them. And then offering options — not just a no. “I can release a product on risk to the warehouse so we don’t lose the manufacturing window. But I’m not releasing it to market until the investigation is closed.” That’s the difference between policing and partnering.
The strongest signal of a healthy quality culture is when people come to quality voluntarily to say they messed up. When employees feel safe enough to surface issues without fear of blame, the system is working. When they hide problems because last time someone made a big deal out of it, or because they’ve raised issues before and nobody cared, the system is failing, and you probably won’t find out until an investigator does.
Yeime has seen both failure modes firsthand. After inspections, she’s had SMEs say “I knew about that,” either because they were afraid to escalate or because they’d raised it and been ignored. Both are organizational failures. Her response: don’t wait for employees to come to you. Have the conversations proactively. Ask what would worry them if an inspector showed up tomorrow. Then address those things. Nobody should be in a position where known issues surface for the first time during an inspection.
Preparing people for inspections is about competence, not scripts. Employees should be able to explain what they do, how they do it, and how it connects to the procedure and to patient safety. That ability comes from practice via internal audits, self-assessments, and cross-functional meetings where people explain their work and its impact on other departments. It doesn’t come from handing someone a printed SOP to read in front of an investigator. If the SME can’t present their own work and the QA administrator has to do it instead, that’s a problem to fix before the inspection, not during it.
AI is useful. Accountability is still yours. Yeime uses AI daily and sees real value in how it processes data, analyzes metrics, and accelerates review. But she referenced a recent FDA warning letter involving a facility in India where the company’s response to a question about process validation was essentially that AI didn’t tell them it was needed. That made it into the warning letter. The FDA has implemented ELSA to review INDs and NDAs, and the agency can process data faster because of it. But the final decision — the quality judgment — sits with people. AI can hallucinate. It can pull bad data. It learns from what you give it. In Yeime’s view, AI will not replace the judgment that comes from historical experience, pattern recognition, and the gut instinct that tells you to take a closer look.
Human in the loop is not a buzzword. It’s the operating principle. Both Yeime and Nick agreed on this. Even as AI matures, someone will still be signing off. The question is whether that person is actually reviewing what they’re approving or treating it like mortgage documents: signing without reading. In a GxP environment, that distinction is the difference between compliance and a warning letter.
Three moves to embed inspection readiness into your culture for the long term. First, design your QMS around lifestyle thinking, not compliance checklists. Don’t focus on check, check, check. Make sure everyone understands the process, understands the why, and understands the impact of their work on patients and product quality. Second, make integrity and decision transparency non-negotiable. You cannot compromise patient safety. You cannot compromise integrity. Make that clear and unambiguous across the organization. Third, build two things simultaneously: a strong relationship between quality and senior leadership (so they understand the value and spread it top-down) and a psychologically safe environment where employees surface issues without fear of blame.
One thing to bring back to your team
Ask yourself whether your quality system is designed for the organization you actually are, or for the organization you wish you were. Then ask:
Are there requirements in your procedures that go beyond the regulation, and is your team actually following them, or are you creating audit risk by writing aspirational SOPs?
If quality raises a risk to leadership, what happens? Does it get addressed, or does it get ignored?
If an operator made an error tomorrow, would they come to quality on their own, or would you find out during an inspection?
Can your SMEs explain what they do, how it connects to the procedure, and why it matters for patients without reading from a script?
Yeime Martich is Vice President of Quality Assurance at TerSera Therapeutics, where she has led the quality organization for over three years. She has 25 years of experience in pharmaceutical and medical device quality systems, with a career dedicated to compliance, quality system design, and inspection readiness. Before TerSera, Yeime spent over seven years at Melinta Therapeutics in quality systems leadership and over 11 years at Hospira in global compliance roles, where she built and oversaw internal audit programs across manufacturing sites in the US, Canada, Europe, India, and Australia. She also held a quality engineering role at Abbott.
Connect with Yeime on LinkedIn here.
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