Meet Melisa Williamson, Director of Quality Assurance

PharPoint is excited to welcome Melisa Williamson as our new Director of Quality Assurance.

Melisa brings deep expertise within quality systems and process improvement, and has worked in the clinical research space since 2011. Her experience spans multiple GXP environments, including managing and directing GCP Quality Assurance (QA) at various sponsors and CROs. Melisa is an experienced speaker within the clinical quality space, with topics including Risk Based Quality Management (RBQM) and Quality by Design (QbD).

Q: We’re so excited to have you here! Can you tell us a little about yourself and your background?

I started my career in a GXP environment where I managed training, controlled documents, and process improvement. Besides being a great foundation in Quality Assurance,  I had mentors that helped me develop a quality philosophy that still drives everything I do.  I spent some time with Computer System Validation and Laboratory Information Management Systems, ensuring proper validation and successful system implementations (QMS, LMS, LIMS) before moving into an auditor role.  Finally, I spent the last eight years focused in GCP, overseeing all aspects of quality assurance at Sponsors and CROs.

Q: Who or what has been the biggest influence on your approach to quality?

I am lucky to have had great mentors.  R. Edward Zunich, author of Practical Process Improvement Manager’s Guide and A Program for Market Leadership in the 21st Century, was one that made a huge impact.  He helped me bring Practical Process Improvement methods and tools to clinical research organizations and was always there to talk about strategy when a crisis arose. He unfortunately passed in 2023 but his work lives on.  His work, and therefore mine, is strongly influenced by W. Edwards Deming, Fredrick Winslow Taylor, and Dr. Walter Shewart.

Q:  What’s one aspect of clinical quality that’s particularly top of mind for you right now?

Of course it’s Quality by Design and the Risk-Based Quality Management that is at the heart of the latest ICH guidance update (ICH E6 R3).  Being recently adopted by the FDA makes this a hot topic for our industry.

Q: Looking ahead, what excites you most about your new role at PharPoint?

The team here is more collaborative across functions than I have ever seen- anywhere!  I’m most excited about the organic quality culture that happens as a result of these long-term close working relationships. Our teams have built trust over time.  I’m looking forward to working with our clients to build proactive risk management into the design and management of their studies.

Q: Outside of work, how do you recharge?

I am a musician and love to play with other musicians.  I currently play bass and guitar in a local cover band.  My favorite part of playing music is the magic that happens when we all come together on a beat or melody.

Quality has always been a cornerstone of PharPoint’s approach to clinical trial services. We are thrilled to add Melisa’s expertise to the team. To learn more about quality assurance at PharPoint, we invite you to reach out to our team.