Quality assurance, auditing, computer system validation, and clinical trial oversight.
I graduated with a biochemistry degree and loved the idea of working in life sciences but hadn’t really thought about Quality. But, then I took a job in Document Control at a very small biotech and I ended up doing tons more in QA. Due to a business need as it was just me and the QA director. That meant I got the gift of lots of 1:1 training and mentoring. I discovered that I really liked it and over a matter of years I got more and more experience and exposure. Quality is a very cross-functional area of specialty so there are seemingly unlimited options for where you might want to apply it. I completed a lead GMP audit training course, to kind of add another string to my bow, and then was headhunted by a former colleague to a role that specifically focused on clinical QA in early-stage studies. I’ve worked at small to medium companies almost exclusively and have gotten extraordinarily fortunate with my opportunities. For example, I got to help implement a brand new GCP lab from scratch…who wouldn’t jump at that chance, right? I particularly find GCP patient safety and ethics to be fascinating and so incredibly important. And then I knew both Rob and Ian from previous working relationships, so when I saw a chance for us to work together again here at Dark Horse, I took it!
I felt sure it would provide me with the chance to do a wide range of different things and sure enough, that’s been true. There’s no way to really anticipate what working here will be like because many of the scenarios we’re supporting aren’t something you’d imagine. The range of possibilities seems nearly endless. Even only three months in I’ve noticed that I have opportunities both to hone my current skill set and build on it as well. The range of experience here is so staggering that we learn an extraordinary amount just by working with our DHC colleagues.
Oh, absolutely. My father and I had a tradition: we’d let an encyclopedia fall open and whatever page we found ourselves on is what we would read and learn about that day. I think that gave me an appreciation for the vast amount of knowledge out there, and made me want to dig in and learn everything I could. In the UK we make our professional decisions a bit earlier than one does in the states, so by the time I was 16 I had identified biochemistry as my direction of choice.
Regulatory expectations in the UK can be slightly different from the States in that the chance for clinical trial sponsors to be inspected tends to ramp up earlier, which perhaps provides more to think about at an earlier stage. I personally find that approach can be helpful because it ultimately leads to an awareness of quality systems earlier in the process. If I could flick one switch it would be to encourage everyone to start mulling over the quality elements and Regulatory best practices earlier so they are more prepared for what is coming in the later stages. There is always more than one way to do things and you might need time to work out which way works best for your company.
My husband is also a detail-oriented person who funnily enough works in Quality too! Between us I suppose I’m slightly more the planner, the one with the (many) spreadsheet(s), but he brings his own style of planning to the table as well. For our wedding he was the one printing out everyone’s to-do lists and keeping it all moving forward!
Right! We’d been together for eleven years but this wedding was a long time in the making due to #pandemiclife. We got engaged in 2018 and had everything booked for April 2020. COVID had other plans, though, and by the time we finally got married in October of 2021 we’d been waiting 18 months and been through 3 failed attempts at setting a date. We were overjoyed to have it finally made official!
Oh, absolutely! Anything active—in fact, my husband and I got engaged on a cycling holiday. We also do lots of mountain walking, camping, rock climbing, skiing etc. COVID has wreaked havoc on many an activity, though, including ours. Rock climbing might sound like an outdoor activity but when it’s in an indoor climbing gym it most certainly is not. I look forward to the day when we can get back to that in earnest. I talk about a lot of exciting stuff but it’s not like I’m intending to climb Everest or the like—for some of these group activities I like to say that I show up for the post-activity wine and cheese. I refer to myself as a “soft adventurer!”
Q: When are kitten pictures a win?
Lyndsey and Josh: newlyweds!
Lyndsey’s kittens are sisters from the same litter and are inseparable! The one on the left is Iaso, named for the Greek goddess of recuperation because at 7 weeks she recovered from a limp. The one on the right is also named for an ancient diety, but in this case, the Roman goddess, Juno. Could they be any cuter??