What Drew You to a Career in the Life Sciences Industry?
I graduated from college with a chemical engineering degree. My first professional job in a QC lab helped me learn the ropes about compliance, documentation, and all that goes into manufacturing medical devices and pharmaceutical products. The company culture left a lasting impression on me that has since been a first principle to how I operate and make decisions on a daily basis: the patient is the reason for everything we do, even when day-to-day tasks might seem mundane or frustrating. I’m in technology now, but it is technology that solves for manufacturing problems. We are in many different industries, but it’s still life sciences that continues to motivate my mission of modernizing quality approaches. It’s life sciences because of that connection to helping patients and assuring the products they rely on are manufactured safely, effectively, and efficiently.
Tell Me About Your Current Role and What You Do.
I am the Head of Quality at Tulip. Tulip provides technology to digitize frontline operations from labs to master batch records to logbooks—really anything. I work with life science customers to understand their problems and help them use digital tools to be compliant and validate their products in a way that demonstrates the control they need, but that also fosters rapid innovation and enables execution of a continually improving environment. I also work with our product engineering team to help bridge the needs of our regulated customers with the internal development of relevant solutions.
Tell Me About a Project You’re Proud of
I co-led the development of the ISPE Good Practice Guide: Validation 4.0 that was published at the end of June this year. It started off with trying to solve a problem in 2019, looking for ways to modernize quality and validation approaches in a way that helped support the changes that were happening in the world. This work evolved from writing a few articles and speaking at a few conferences and it developed into writing a Good Practice Guide. It was written by a really cross-functional team of consultants, technology representatives, and experts from life science companies all working together from across the globe. The team included people from the US, Brazil, England, Spain, Switzerland, Germany, and Thailand all aligned on the same mission, and that’s really exciting.
What Do You See Next for Your Area of the Industry?
Obviously, the rate of change is increasing every day. Working for a technology company, I’ve heard from a lot of customers over the years that are still resistant to adopting digital technology, or slow to adopt. They say they don’t know how they will defend compliance to regulators and use that as a bit of a crutch. But I am starting to hear a shift in messaging at conferences and directly from regulators that are saying, “We want you to innovate. We don’t want to be holding you back.”
My hope is that it will bring about a shift in perception and help foster innovation. For instance, the European GMPs are currently under revision—Chapter 4 on Documentation, Annex 11 on Computerised Systems, and a newly drafted Annex 22 on Artificial Intelligence. These might come across as small changes, but I think they will have a big shift on the industry, and I am excited about what the future holds. Rapid change can be scary for regulated environments, but this is the heart of where innovation can have real impact.
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Are you an ISPE Member looking for a better way to connect with your colleagues from around the globe? Or are you a Member seeking information on new trends, issues or concerns affecting your profession and your day-to-day work life? Join an ISPE Community of Practice (CoP). CoPs are groups of ISPE Members with a common interest and similar job functions who collaborate on topic-specific discussions using the ISPE networking forum, ISPE Engage.
