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ISPE Member Spotlight : Dr. Randy Perez

ISPE Member Spotlight : Dr. Randy Perez

Dr. Randy Perez retired from the position of Director of Information Governance and Management for Novartis Pharmaceuticals in 2015. During his 32-year tenure at Novartis his responsibilities included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oaxley, and data privacy. He served on several global teams dealing with computer systems compliance issues and authored many of the firm's global GxP compliance policies. Prior to joining IT, he worked as a chemistry group leader in process research, managed a chemical manufacturing process validation initiative, and ran both a GMP training program and a QA validation group for pharmaceutical operations.

Dr. Perez has been an active member of ISPE for more than 21 years. He was instrumental in the formation of GAMP® Americas and continues to be involved with the group. He is currently part of the team working on a new GAMP® Guide and has been lead author or team member for five other GAMP® guides. A member and past Chairman of the ISPE board, Dr. Perez has helped plan numerous annual meetings and is a frequent trainer and continuing education speaker for ISPE and other organizations.

How did you come to dedicate your career to the pharma industry?

When I was graduating with my Ph.D. in organic chemistry, Pharma was where everyone wanted to go. The science was the most challenging and the output was products that helped people. I only interviewed at one non-pharma company, and it was clear before the end of that day I did not want my contribution to humanity to be a plastic that would prevent car dashboards from cracking after extended exposure to sunlight. How I got to Computer Systems Compliance is a long story for another time.

Can you share some of the more interesting experiences and successes you’ve had with the Society during your tenure?

ISPE gave me the opportunity to meet and become friends with many different people from all across the pharmaceutical industry. In the early 2000s I attended the summer strategic planning meetings where I really learned how the society worked, and in a low-pressure environment, met and befriended many of the leaders. Through conferences and other interactions, I made friends within FDA and some of the European regulators, which gave me a useful sounding board for ideas that were percolating within GAMP® or even within my company. But best of all are the friends I have made with other volunteers. Conferences are great, but the dinners with these friends and nights in the bar afterward are better. And you’d be surprised how much good work is done over a beer or two.

What are your thoughts on the state of the pharmaceutical industry today as opposed to how it was in 1980?

Unfortunately, there has been a dismal decline in public perception, which in my view is at least partially self-inflicted. When I joined the industry in 1983, Pharma was the most admired manufacturing industry. Now it’s one of the most reviled. It is perceived as greedy (even I think prices are out of control) and untrustworthy. It isn’t helped by certain politicians who espouse things like distrust of the COVID-19 vaccine, but a lot of it results from overemphasis on short term share value. In 1983 the vision was where the company could be in five to ten years, not what share value would be at the end of the quarter.

Why would you tell someone that they should join ISPE or if already a member, why should they get involved?

You get back what you put in, and the more you put in the more people seek you out for more. It’s an autocatalytic reaction (that’s the chemistry nerd in me).

Being so deeply involved in GAMP® gave me critical insights in where industry and regulators were heading. By putting in the work, I developed a reputation as a global thought leader for computer systems compliance, which helped me within my company and in dealings with regulators. They didn’t always agree with me, but they listened seriously.

What do you hope to see happen with the Society in the coming years?

I hope that ISPE continues to be a source of technical excellence, continues to provide a platform for members to network and grow professionally, and continues to be a trusted partner of both industry and regulators, acting as an advocate of both.