23 Questions with Lisa on Quality Assurance
23 Questions with Forge is a fast-paced series where our team members are challenged to answer 23 rapid-fire questions about trending topics in gene therapy development.
This episode of 23 Questions highlights Lisa Genco Fisher and Quality team, one that plays a role in every stage of our AAV production. Learn more about quality at Forge, the standards that guide our work, Lisa's love of theater, and her personal connection to our work.
Watch the full video below!
Read the interview:
Hi! Can we interrupt you for a quick interview? It’s just 23 questions…
Lisa: Hi! Yes, of course.
For those who may not know, can you introduce yourself?
Lisa: I am Lisa Genco Fisher, and I’m a senior manager of Quality Assurance at Forge.
Give us the 30,000-foot overview. What does “Quality” mean here at Forge?
Lisa: Our quality unit ensures that our manufacturing processes, drug products, and their release go without a hitch.
Why is Quality such a large function in a CDMO environment?
Lisa: In a nutshell, we ensure that the products leaving our facility are safe for patients. That responsibility touches nearly every part of the organization.
Where do you fit into the Quality organization specifically?
Lisa: I manage our QA Tech Ops team. We partner with all the labs to support testing, manufacturing, and release within specifications.
I have to ask—is that Elphaba from Wicked?
Lisa: Yes! Theater has been a lifelong love of mine.
If you were in a musical, what role would you play?
Lisa: I’d be the stage manager. Now that I think about it, I realize how similar that role is to what I do in QA!
Okay, I need you to explain that. How is QA like being a stage manager?
Lisa: The stage manager works behind the scenes to ensure every performance runs smoothly. They make sure the right people are onstage at the right time, the script is followed, safety checks are done, and any changes are reviewed before the curtain goes up.
So is that what you’re doing on the manufacturing floor?
Lisa: Exactly! The FDA sets the stage with guidelines that all CDMOs must follow, and we operate within that framework.
Interesting. I’d love to see it in action!
Lisa: Yeah! Actually, I have to go check in with Mike Moffo. Want to come?
I’d love to! Let’s go.
You were telling us about the FDA’s guidelines. Are they the “script” your team follows?
Lisa: Exactly! We ensure everyone follows the approved “script”: our SOPs, batch records, test methods, all of the processes that we have put in place to ensure we are making our clients great quality drugs.
Stage managers collaborate with everyone…actors, musicians, lighting, costumes. Do you work cross-functionally like that?
Lisa: All the time. QA touches nearly every department. Oh, there’s Mike!
Mike: Hi Lisa! Usually you’re behind-the scenes…what’s going on?
Lisa: I know. Today, I get to be the star of the show!
Mike: Of course you are! I’ll let you wrap up here. Catch you in a few.
Lisa: OK, thanks!
Who are some of your closest collaborators?
Lisa: We work closely with PMO (like Mike), QC, Analytical and Process Development, Manufacturing and Manufacturing Support, Supply Chain, and Regulatory. Our role is to help keep the entire production aligned and on script.
Let’s walk through the QA process. I imagine there’s a lot that happens before the “show” even begins?
Lisa: Absolutely. QA verifies documents, processes, equipment qualifications, and data before manufacturing begins, and again before any batch is released.
I see! In theater, there’s no improvising if you want a polished performance. Is there room for improvisation in manufacturing?
Lisa: Not when it comes to compliance. QA ensures that all departments follow the agreed upon script to protect the integrity of the process.
With analytics, and upstream and downstream, oh my (hehe)…AAV manufacturing must generate a mountain of data. How do you keep track of it all?
Lisa: Haha, yes we do! We use Veeva as our quality management system, and we leverage LIMS to manage and track our analytical data in a structured, compliant way.
What exactly is LIMS?
Lisa: LIMS (stands for Laboratory Information System) is a module within Veeva that tracks our testing results and automatically generates our COAs. Forge was actually an early adopter of this system.
Cool! And what is a COA?
Lisa: A COA is the Certificate of Analysis. “Ping!”
Lisa: I need to take care of something in the doc room.
OK! But first, a quick fun question—is that your puppies I saw on your screen? Tell us about them! (camera zooms in to phone screen photo)
Lisa: They’re my favorite audience after a long day. Penny and Stella bring me joy, make me laugh, and are always ready for belly rubs.
Welcome to the doc room!
Gotta stick to my own script… so back to Quality! What happens if someone on your team finds something that isn’t quite right?
Lisa: Just like a rehearsal would stop if there’s a safety concern, QA can pause production or prevent release if something is out of specification or compliance. We investigate, correct, and ensure everything is resolved before moving forward.
Once all the data is approved and a batch is released, what happens next?
Lisa: All approved documentation is finalized in our systems and the physical paperwork is archived here in our document room for record retention.
In today’s digital world, is that paper trail still required?
Lisa: Yes, it is. FDA regulations require formal documentation retention, and there’s actually a lot of daily traffic in and out of that room to maintain compliance.
I bet. I noticed your tattoo. Do you mind sharing the story behind it?
Lisa: I don’t mind at all. It’s in honor of my cousin Ben, who was born with a rare disease called heterotaxy syndrome. He had three open heart surgeries before he was five and lived until he was 22. Losing him in 2021 was incredibly difficult.
That must give you a very personal connection to the work we do here.
Lisa: One hundred percent. His life inspired me to pursue a career where I could help bring hope to patients like Ben and their families. There are so many people affected by genetic diseases who are waiting for treatments like the ones we manufacture here with our clients. I’m proud to play a part in that.
As a fellow theater lover frequently in the audience, I’m grateful for all the behind the scenes work stage managers do. And I’m grateful for QA too!
Right?! Was that a question? Our time is up! I have to go find Mike.
The show must go on! Thanks Lisa.
