Kimberley Buytaert-Hoefen, Ph.D.

Kimberley Buytaert-Hoefen, Ph.D.

Kimberley Buytaert-Hoefen, Ph.D.

Principal Consultant

Kimberley has over 19 years of experience in research and development, commercial pharmaceutical and the medical device industry. Daily, Kimberley works closely with clients to develop and implement effective, cost-efficient compliance solutions in accordance with client needs. She also performs GXP audits, conducts laboratory data review including chemistry, microbiology, and data integrity assessments.

Work Experience

Prior to joining Parexel, Kimberley held positions as a Lead Scientist at Navigant Biotechnologies and appointed as a Consumer Safety Officer at the FDA, where she trained at performing surveillance, for cause, and pre-approval establishment inspections and specialized in pharmaceutical and medical device inspections with an emphasis on biotechnology, gene/cell therapy and sterile processing.

Other notable experience includes being qualified in the authoring, review, and coordination of regulatory documentation. FDA trained at performing surveillance, for cause, and pre-approval establishment inspections and being highly skilled at laboratory data review.

Education

Kimberley holds a Bachelor’s degree in Psychology at the State University of New York, Binghamton and Master’s and Doctorate degrees in Neuroscience at the University of Colorado, Boulder. She completed two post-doctoral fellowships at the University of Colorado Health Sciences Center where she specialized in embryonic and adult stem cell research.

We are always available for a conversation.

*