January / February 2024

CoP Leader Profile: Lorrie Vuolo-Schuessler

Marcy Sanford
CoP Leader Profile: Lorrie Vuolo-Schuessler

Lorrie Vuolo-Schuessler has been involved with ISPE and GAMP® projects since 2002. She has authored or co-led 11 ISPE GAMP-focused guidance documents, including ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and the ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is Immediate Past Chair of the GAMP Americas Steering Committee, a member of the GAMP Global Leadership team, and a co-leader of the Computer Software Assurance (CSA) Special Interest Group (SIG). Additionally, she has contributed to multiple ISPE and GAMP webinars, expert exchanges, conference presentations, and trainings.

Early on, Lorrie knew she wanted to work in the pharmaceutical industry, but her path to a career in quality assurance and computer systems compliance started with an interest in chemistry. “I had an older cousin I really looked up to who studied chemistry and then worked in the pharmaceutical industry. Where I grew up in north New Jersey, there were a lot of pharmaceutical companies, and I wanted to follow in her footsteps,” said Lorrie. “My first job after college was working at the America Health Foundation, a cancer research center where they were doing cutting edge research on nutritional chemistry.”

From there, Lorrie worked at Revlon and Ciba-Geigy before joining GSK, where she started as a scientist studying drug metabolism before moving into safety assessment and quality assurance and computer systems compliance.

“This was at the time when Good Laboratory Practice was being introduced into drug metabolism labs and GAMP was being introduced in the US,” Lorrie said. “And I started working with other ISPE members on the laboratory SIG, and eventually co-lead the team which wrote the first edition of the ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems.”

Throughout her career, Lorrie has been instrumental in ensuring that the best quality systems are in place and GAMP has helped support that. “GAMP is focused on quality, critical thinking, and risk-based approaches. Instead of creating reams of useless information, it focuses on the quality elements of the project, not just checking boxes.”

“I think that is where the pharmaceutical industry needs to go. That’s what the CSA draft FDA guidance is doing, really trying to get people to focus on the quality of what they’re doing and not the perceived regulatory compliance aspect of it. Because if you build quality into your processes and into your product, it will be compliant. But if you are only looking at the compliant aspects, you may miss quality. It is really important to focus on the quality aspects of what we do and not just what we perceive to be a compliance cause.”

In addition to helping shape her career, Lorrie’s involvement with GAMP has given her a group of lifelong friends. She says the main advice she gives to any young person is to get involved. “I look at the people I’m involved with in GAMP and think I am surrounded by amazingly intelligent, brilliant people, who have done so much and brought so much into the industry, and I feel honored to be among them. I’ve traveled with them, worked on guidance with them, and what we’ve done has influenced the industry in a positive way.”

Last year at the 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, Lorrie was honored with ISPE’s Richard B. Purdy Distinguished Achievement Award. Named after one of the Society’s founders and most accomplished presidents, the award honors an ISPE member who has made significant, long-term contributions to the Society.