Once in a while, we want to showcase the incredible people in our consulting group by digging under the CV to hear their stories and what motivates them in this field.
A few months back, we showcased Neal Siegel, PhD, who shared his perspectives on system-level thinking, consent decree lessons, and what experienced Quality leaders actually focus on when the stakes are high. Then we talked with Trey Thorsen, MS, RAC, who has worked as a regulatory consultant (with a 510(k) specialty) for six years.
Today, we are showcasing Jeff Jackowski, who has about 40 years of experience in pharmaceuticals, nearly all of which has been spent in hands-on management. His work typically covers tableting, aseptic manufacturing, terminal sterilization, and biotech, as well as some device work. Over that time, he’s built a track record of preparing sites for FDA inspections, changing site cultures, and running sites himself.
Jeff sat down with Sara VanGorder, one of our account managers (the two are finishing up a project together now). They covered the strengths Jeff brings to a site, the engagement he’s proudest of, what working under a consent decree looks like from the inside, and when account managers should call him. Highlights are below, and the full conversation is in the video.
The site team has to own the fix
Jeff’s approach to pre-approval inspection (PAI) readiness goes beyond walking a site and pointing out problems. He knows what needs to change, but he asks the team questions, wants them to bring their own ideas, and works with them until they buy in. His reasoning is practical. “Once a consultant or somebody leaves, they’re going to live with it.”
The people who stay have to feel they contributed heavily to the corrective action. Depending on the group, he gets there with storyboards, one-on-ones, audits, or working alongside them on the remediation.
That style carries into how he changes a culture. “I don’t rule with an iron fist,” he says. He describes himself as approachable, and a lot of his former directors still keep in touch. He also sees quality as part of a collaboration that spans manufacturing and management. He understands what it takes to make a product and bring it to market successfully, and after this many years, he has plenty of ideas to suggest.
Jeff says he has good relationships with the FDA as well. During one inspection, back when he was still working in industry before he started consulting, an investigator came up to him and said, “We know you, and if you’re here, we know it’s going to be okay.” He has also handled the situations where things have already gone wrong, including warning letters, consent decrees, and compliance problems tied to import alerts.
Three years in Istanbul
The accomplishment Jeff is proudest of dates to his time as a VP at a virtual company that signed development and manufacturing agreements with partners all over the world.
One of those partners, in Istanbul, had eight ANDAs, all sterile injectables. As Jeff explains it, the FDA hadn’t approved anything from Turkey at that point. Some Turkish companies had hired outside firms to get their drugs approved for the U.S. market, and those efforts had failed.
Jeff visited the site and came back with a blunt report for the company’s president. This was going to take a lot of work, and it wasn’t going to happen overnight. The site had culture and SOP issues, and its equipment hadn’t been properly qualified. The processes needed to be challenged too, because nobody knew the actual critical manufacturing parameters.
The president’s answer was that he had already told the board the products would get approved, so Jeff needed to go get them approved.
Jeff spent a good three years flying back and forth. With his director and an outside consultant who handled the facilities, engineering, and calibration side, he rebuilt the site’s SOP system, wrote the SOPs, and trained people to perform quality, engineering, facilities, and operations functions in a pharmaceutical environment. Sterile technique was a big part of it. The equipment itself was good, but it hadn’t been maintained. The site’s idea of preventive maintenance, he says, was “if it breaks, fix it.” He’s clear that none of it would have worked without upper management buy-in, and they got it. His team also signed off on the site’s investigations along the way.
When the FDA came to inspect, Jeff wasn’t supposed to be in the room much. Inspectors usually don’t want someone like him there, he says, because they want to know whether the site’s own people can do the work once the consultants leave. He got in by pointing to a possible language barrier and then said very little. The site got through the inspection, the FDA was impressed, and the investigators recommended approval.
The result Jeff points to most came two years later, when the FDA came back and the site was fine again. Issues come up in any manufacturing operation, from investigations to CAPAs, and the site handled them well.
“They got it,” he says. “They used it.”
As they were leaving, Jeff recalls, his director had tears in his eyes seeing how happy the site’s people were. Jeff describes it as the first company ever approved there, and says the prime minister came in for the occasion. Then Jeff put his backpack over his shoulder, and his director asked what was next. “We’re going to India,” Jeff told him. “We’re going to do this again.” And they did.
A virtual company with investors who mean business, he says, needs you to be successful the first time.
Inside a consent decree
Jeff was also hired as a site director by a major pharma company after it came under a consent decree. A decree lays out specific items with dates attached, and at his site there were 50 or 60 of them, each broken into lettered sub-items.
Every one meant remediating, changing or writing SOPs, implementing them, and training people. Each fix went back to the FDA with a committed date. A third party, usually a large consulting firm, then worked alongside legal and the FDA to verify that the corrective action actually fixed the problem.
Jeff did well with that process and with the people in it. FDA representatives sat in on his change control and investigation meetings and got to know him. Another company under a consent decree hired him after hearing how that one went. Many of the FDA staff he met during those years have since retired, but they still have their contacts, and so does he.
Reading the culture you’re in
Work in Turkey, India, and across Europe taught Jeff to fit his approach to the people in front of him. His example is a car horn. In India, honking is no big deal; it just means get out of the way, I’m coming through!
Elsewhere, honking at someone is a problem. Of course, horns have nothing to do with pharma. The point is that how people think and the personalities in the room vary from place to place, and you have to manage that or you won’t make progress. “You can’t get too frustrated,” he says.
When to call Jeff
Sara asked what account managers should listen for when matching Jeff to a client project. His answer: any potential customer with a tough issue who needs advice or someone to resolve it. “There’s a 99.9% chance I’ve been there,” he says. “I’ve been in their shoes.” That includes manufacturing problems, FDA issues, culture change, inspection prep, and “any of the unknowns” in pharmaceutical manufacturing.
He takes easier projects too! He once analyzed incoming components for a major pharmaceutical company, physically sampling and releasing them. The project he and Sara are wrapping up now relates to a third-party logistic warehouse, and Jeff has served as the Quality representative for a 3PL for a major company.
He follows the chain from how components are made, to the role their quality plays in a finished product, through distribution. He also knows the operations side, from production supervisor up to vice president, and how Quality can make each of those jobs, and the company’s position, better.
Sara added one more point from her own experience: Jeff is responsive, and he gets back to both The FDA Group and the client in a timely manner.
The proof is in the pudding
Jeff’s view is that good systems prevent problems.
Validated systems, strong analytical methods, proper training, and incentives for people to do their jobs cut down on investigations and issues, and people who feel supported are more willing to speak up. He wants the people he works with to be as successful as they can be in their next job, beyond the one they’re in now. Former colleagues and clients around the world still call him, he says, and he credits that approach.
He traces it back to his upbringing: work hard, treat people like human beings, and pay attention to what they might be going through, because problems at home and at work affect each other.
Jeff Jackowski is a consultant with The FDA Group based in Central New Jersey, just outside Princeton. He has about 40 years of hands-on management experience in pharmaceuticals, covering tableting, aseptic and terminally sterilized manufacturing, and biotech, with some device experience. He’s served as a vice president at a virtual company that partnered with manufacturers worldwide and as a site director at a major pharmaceutical company operating under a consent decree. His consulting work includes PAI readiness, remediation, culture change, responses to warning letters, consent decrees, and import alerts, and Quality oversight for third-party logistics operations.
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