"It had been challenging to find a Quality consultant who understood GCP/GMP/GLP regulations, was flexible, and able to understand our company and our progression. From my first conversation with Judy though, it was clear she would make a significant impact. And she is by helping us build an outstanding and solid Quality Management System.
“She first met with key leaders to gauge the Quality culture. She also conducted a thorough review and gap assessment of our facilities and systems. There were many improvements to be made, but she took the time to fully understand our people, our challenges and our existing company culture before presenting us with an Quality Improvement Plan with prioritized goals and objectives. The plan was reasonable, impactful and rooted on responsibility and accountability. There was a lot of work to be done! But Judy was there every step of the way, supporting us with the tools, training and education needed to successfully execute each goal.
“Judy is passionate, responsive, and knowledgeable in all aspects of the drug lifecycle from beginning to end. She fully understands GCP/GMP/GLP requirements, is quick-minded, can untangle issues, and can get to root causes quickly. As a partner, she is flexible in her approach so that our people feel part of the process, while making sure that we comply—and that people understand how it all works together and how it is applicable to their role.”
Director of Quality Assurance
AGTC, a clinical-stage biotechnology company
that uses a proprietary gene therapy platform
to develop transformational genetic therapies
for rare and debilitating diseases
“Judy is a great Quality lead for any start-up life sciences company. There are many traits that make her a great fit, including a high level of integrity, approachability, consensus-building skills, and flexibility. She is committed to implementing a robust internal QMS for Quad and educating our people appropriately.
“Judy’s deep knowledge of Quality along with her broader understanding of the operational side of our business makes her more effective as a Quality leader. She thinks like an executive. She has implemented Quality requirements that do not inhibit innovation or product development, but add strategic value.
“I highly recommend Judy because she understands how companies can think about and integrate Quality early on. Her approach and mindset helped make Quality a core element of our business and our company culture.”
Sean Kevlahan, Ph.D.
Chief Executive Officer and Co-founder