InTouch
January / February 2025

Volunteer Profile: Brandi Stockton, GAMP® Americas Community of Practice Chair

Marcy Sanford
Volunteer Profile: Brandi Stockton, GAMP® Americas Community of Practice Chair

Brandi Stockton is Founder of The Triality Group, LLC, where she provides quality, regulatory, and compliance consulting services for life sciences companies. She has more than 20 years of GxP experience, with a specialization in computer systems quality and data integrity. Brandi joined ISPE in 2014. In addition to being chair of the GAMP Americas Community of Practice, she is a member of the GAMP Global Steering Committee. She is also Co-Lead of the GAMP Global Software Automation and Artificial Intelligence Special Interest Group, leading the team working on an ISPE GAMP Good Practice Guide on artificial intelligence and machine learning, and Vice President of the ISPE Great Lakes Chapter.

How did you become interested in working in the pharmaceutical industry?

I was studying to be a paralegal and you had to find an internship for the last part of the program. Most of the members of my cohort went to law firms. At the time, the Diagnostic and Statistical Manual of Mental Illness (DSM-5) had undergone updates, and articles about mental illness, therapy, and Pro-zac were all over the news—on the cover of magazines like Newsweek and Time.

I am from Indiana where Eli Lilly is headquartered. Prozac was their product, and I thought it would be a great place to learn about not only what was happening in the medical field, specifically with the DSM-5, but also mental health generally, and to look at law from a different perspective. I think it was the first time Eli Lilly had someone ask to be a paralegal intern in their legal department.

After graduation, I decided I really wanted to do something that helped people. I worked for a law firm that focused on civil rights and one that focused on immigration for hospital staff. I received a call from Eli Lilly asking me to cover a childbirth leave and spent much of the next 14 years working there in sales and marketing and quality control labs, setting up good manufacturing practice libraries. In between a couple of contracts, I also worked at Riley Children’s Hospital and the American Diabetes Association.

What do you enjoy most about your work?

I wear a lot of different hats: overseeing operation strategy, managing client relationships, and providing quality and regulatory consultancy services for life science organizations. I really enjoy being able to bring people together to collaborate and to design teams based on a company’s specific needs. I enjoy knowing that what I do truly helps organizations. I like to solve complex problems and help people understand what is possible, like what we are exploring in the artificial intelligence space right now.

What do you see next for your area?

There are great technologies out there and in development. But we, as an industry, have not invested enough time upfront to train and prepare people and we have not always learned from past opportunities. I think organizations are beginning to have a better understanding of the true challenges they face when trying to implement innovative technologies like artificial intelligence and recognizing that they should be seeking advisors and trainers.

In my experience, those that have reached out for external help have been able to more easily and successfully adopt new technologies. I hope we’re going to see more and more connections, more collaboration, and sharing of success stories. Because once we develop trust and confidence, have the processes in place, and get the training and upskilling of people right, then we’re going to see some truly amazing products and therapies.

What advice would you give emerging leaders in the pharmaceutical industry?

Get involved in something that is a challenge. If you volunteer for something you don’t know a lot about, you are going to learn so much more as opposed to volunteering for something you’re already an expert in.

Do not undervalue your worth. At ISPE I’ve seen many emerging leaders who sit on the sidelines and think they don’t have anything to contribute right now, but they do. Don’t hesitate to raise your hand, speak up, or ask questions. When you ask good questions, others learn as well. Also, it is okay to walk away from opportunities that you are not learning from.

You are already awesome. Don’t wait to become something you already are.

For you, what are the benefits to being an ISPE member?

I get to help shape the industry and connect with stakeholders that I might not have met otherwise. You may work in operations, but you have little interaction with regulatory affairs, for instance. At ISPE I get to meet people from all those areas. It is a place to go to interact with those stakeholders in a meaningful way.

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