Practice Expert, Quality
began work with DHC in 2017
Quality systems…since the 1990s!
My second grade teacher did a unit on solar systems and she had each of us pretend to be in a rocketship blasting off. We had to keep our eyes closed and we would lean back in our rocketship chairs and we’d fly by each planet, with just her voice guiding us. So of course, in second grade I wanted to be an astronomer and then the next year I wanted to be an archeologist and then later, a meteorologist. Science as the way to empirically understand the operation of the world became my focus and in high school I fell in love with biology and chemistry. I started college with a biochemistry expectation and ended up majoring in biology and minoring in biochem. This was in the 80s when there was an even more notable gender disparity in the field than there is today. I always knew that I wanted marriage and children and I also knew, somehow, that the stay-at-home-mom model wasn’t a fit for me; I was going to be a mom and also a scientist. And sure enough!
This is our second rescue, a Husky-Great Pyrenees-Labrador-Staffordshire terrier mix. Her name is Suki, which means “beloved,” and in this picture she’s just a puppy. (She’s now one year old and 80 pounds, and she still loves a good pool of sunshine!) It’s always fascinating to learn the personality of a mixed breed dog; in Suki’s case, her Husky behaviors and mindsets are dominant! We like to choose large breed mixes not only because we love them but because rescue organizations can have difficulty finding homes for them.
I was a phlebotomist in the 1980s and that was a genuinely dangerous job during the AIDs epidemic. I sort of happened into Quality because it was a new need at the time when I was finding my niche. For a while I did fight it, though, trying to get back into research because people perceived Quality as being limiting somehow. I think it was easy to think of us as just the rule followers, the people who require boring things like proof and documentation and accuracy. But the thing is, meeting those needs with a scientifically sound solution is both challenging and satisfying. The more you understand Quality and build it in from the start, the more efficient and cost-effective any process is. I discovered after a few early jobs that I really enjoyed working with potential, working towards a goal, building Quality infrastructure from the ground up. I like the constant challenge of being able to work with and build something new.
I came to cell therapy in 2000 as one of the earliest hires for a start-up. There were very few regulations in place at that time because the industry was so new, and there wasn’t any infrastructure at the start-up yet either. I had to build my own quality systems without a map, not knowing what the requirements might eventually be and without any pre-existing systems in place anywhere, on the company side or on the regulatory side. I developed a process of weaving together a quality system that borrowed from a medical device example and the best of the process regulations I’d encountered elsewhere. Once regulations came out for the projects I’d been working on, my QS had already been in place for years. It was one of my proudest moments, when regulations got rolled out and we didn’t have to change a single thing. I’d managed to anticipate every potential requirement with something that I’d built completely from scratch.
QS is always a craft; there’s an art to it. You have to bring together the spirit of the law and the letter of the law because a regulation isn’t always specific enough, especially in the early days of any new field. So, if you can anticipate the intent and pay attention to potential pitfalls from the very beginning of each process, it’s possible to get it right the first time.
Quality is everywhere; it’s the umbrella that protects and encompasses every other aspect. I appreciate its neutrality; there is no agenda and no bias beyond simply getting each step right. It probably sounds biased for a Quality person to think this way but I truly believe that the earlier you incorporate Quality Systems, the smoother your process will be. Starting with raw materials and preclinical stages, each and every process, procedure and decision benefits from being seen through a Quality lens.
The fastest way to get where you’re going to is to know your destination and Quality knows the destination. That allows us to map backwards with the destination goal in mind. We are a group that plays the long game, always. QS plays chess, not checkers.
Absolutely; they’re that much more mission-critical. “Quality in, quality out” is always the case, but in C>, proper sourcing is even more necessary than elsewhere. There isn’t an option to sterilize a therapy down the road, so you have to hit the mark early and never let up. Think of how many INDs get rejected because of a failure in CMC. That can often mean that the quality work wasn’t sufficiently robust. Also, if a client is new to these particular regulations, they may not be quite as focused on documentation as a Quality expert will help them become. If it’s not documented, it didn’t happen!
We’re like an SME (subject matter expert). We’re someone who knows our particular area backwards and forwards and focuses specifically on that aspect alone. I’m one of the two quality management experts here at Dark Horse.
I’m called in to each project on an as-needed basis and between me and my colleague Ian Pardo, we interact with every client who needs a Quality lens. If you haven’t worked with us, you’re among the few who didn’t experience a single Quality issue!
Persistence! Determination! And so much stubbornness. We don’t quit. We will work a problem until we’ve isolated the issue(s) because we know what’s at stake.
So many! I’m half Italian and I love to cook; family and food are always front and center. I love horses and big dogs. (See the picture above of my most recent rescue, and just below, here’s a bonus picture of me on our honeymoon in 1994 with a gorgeous horse appropriately named “Goldie.”)
I was a competitive runner in high school and spent a few years in my 30s practicing Tae Kwon Do along with my kids. I made it to brown belt before being sidelined by an injury but those self-defense skills stay with you for life. Oh, and gardening. I love to garden.