Kyeana Knight
Kyeana K. is a Clinical Quality Assurance professional based in Atlanta, Georgia, with over a decade of experience in the biotechnology, medical device, central laboratory, and clinical research industries. She currently works at Astellas Pharma, where she serves in a global quality leadership role supporting oncology clinical trials and ensuring adherence to regulatory standards. Her work focuses on maintaining compliance with FDA, ICH, ISO, and CLIA guidelines to ensure the safety, integrity, and ethical conduct of clinical research.
Throughout her career, Kyeana has built extensive expertise in quality systems, audit execution, risk management, and inspection readiness. She has held roles at organizations including Pfizer, Arena Pharmaceuticals, Advanced Clinical, and Philips Health Systems, gaining broad experience across clinical quality assurance and field engineering. She is highly proficient in quality systems platforms such as Veeva Vault and TrackWise, and has contributed to change management, validation review, and regulatory submission readiness initiatives.
Kyeana holds a Bachelor’s degree from the University of Texas at Austin and a Master’s degree in Pharmacy with a focus on biopharmaceutical and biotechnology regulatory affairs from the University of Georgia. She is also certified as a Certified Quality Auditor (CQA) and a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP). Guided by a strong commitment to integrity, patient safety, and proactive risk management, she is dedicated to advancing high-quality, ethical clinical research that protects participants and upholds scientific rigor.
• Certified Quality Auditor
• Registered Quality Assurance Professional
• The University of Georgia- M.S.
• The University of Texas at Austin- B.A.
• Society of Quality Assurance (SQA)
• American Society for Quality (ASQ)
• Alpha Kappa Alpha Sorority Incorporated
• Church work for the deaf community
• Girls of Excellence, Inc.
What do you attribute your success to?
I attribute my success to over 20 years of experience in clinical research and quality assurance for oncology clinical trials, supported by a strong educational foundation in psychology and kinesiology from the University of Texas at Austin and advanced training in regulatory affairs, all of which have strengthened my expertise and commitment to the field.
What’s the best career advice you’ve ever received?
The best career advice I’ve ever received is to always lead with integrity, prioritize people and their safety above all else, and proactively identify and address risks early to ensure ethical, high-quality outcomes in every aspect of my work.
What advice would you give to young women entering your industry?
I would say understand an international guideline which is called ICH E6 R3, which is good clinical practices. If you can get exposed to that very early and have a very good understanding of its application, not necessarily memorizing it, but being able to think critically through why those are in place, it will take you a long way. A lot of scenarios that come up in the role that I am in are not black and white, there are a lot of gray. To navigate those challenges, I definitely work on building a network of individuals that I can reach out to, phone a friend, so we can talk through it. I try to make sure I have a lot of different resources from various health agencies or regulatory agencies, because a lot of times the trials are global, so many regulatory agencies from different countries have guidance documents about some of these topics, and it helps you to kind of be able to look at it from a different perspective using different language. Just having additional resources, phoning a friend, and definitely having access to guidance documents from other regulatory agencies helps a lot.
What are the biggest challenges or opportunities in your field right now?
In the same vein, being able to identify risks, especially in complicated situations, is a challenge. Being able to be the person to call it out and to kind of stop the momentum can be difficult because a lot of times there's a lot of pressure, because it's about time. So being able to balance time and making a good judgment call in a timely manner, but still being able to progress forward, is one of the biggest challenges.
What values are most important to you in your work and personal life?
My values as it pertains to my work life include working within integrity, putting people first, and making sure that risk or potential areas of risk or failure are highlighted as I see them. I want to put in controls or mitigations prior to that to prevent it from actually turning into something very serious. Outside of work, I'm very active in my church for the deaf community, and really just spending time with my family and making sure that they're taken care of.
Locations
Astellas Pharma
38 preekness point, Dallas, GA 30132