Cristen Brown

Cristen Brown has over 20 years’ experience in the radiopharmaceutical industry. She began her journey with Positron Emission Tomography (PET) drug manufacturing in November 2001 after she graduated from the University of Central Florida with a Bachelor of Science degree. Cristen has participated in many FDA regulated pharmaceutical drug product inspections as part of her over 11-year history in Corporate Quality Assurance (QA). She has numerous trainings and certifications in Quality Management Systems, aseptic processing, and Current Good Manufacturing Practices (CGMP) manufacturing, including auditing, and has held numerous roles in QA throughout the years. These positions included CAPA Specialist, Lead Auditor, and Sr. Director, QA. Cristen has also worked operationally in Quality Control, Production, Cyclotron Services, and as an Assistant Facility Manager at SOFIE before she transitioned to Quality.

Cristen is responsible for providing strategic quality leadership, managing network regulatory applications and submissions, overseeing continuous improvement projects, and for the creation and maintenance of quality systems assuring network compliance at SOFIE to state and federal regulations and requirements. Cristen also manages a diverse team of department leaders in Radiation Compliance & Environmental Health & Safety, Pharmacy & Regulatory, Sterility Assurance, and Document Control. With a proven track record of accomplishments and results in quality, regulatory, and compliance, Cristen strives to continue to build a culture of inclusion and collaboration throughout and beyond the Quality organization.

A native of Florida, Cristen lives in New Smyrna Beach with her husband, Jay, and their smart, sports-loving boy named Jayden. She enjoys traveling, golf, tennis, reading, crafts, and spending time with family and friends.