Brit Valdez Nava has extensive experience leading and managing FDA regulatory filings, developing, and implementing drug and device quality management systems (QMS), overseeing and auditing GMP operations, and supporting international quality certifications. Her previous experience includes managing cellular/gene therapy commercial manufacturing quality operations. She also provided independent consulting for various medical device companies to support their QMS development and regulatory submissions. She is responsible for educating and providing clients with progressive quality systems and their practical applications, including complaints, risk management, and non-conforming product root cause analysis techniques. She has a master’s degree in Regulatory Science from Johns Hopkins University in Baltimore, Maryland.