Dawn Olenjack

• Inaugural member of FDA's dedicated Bioresearch Monitoring Inspectorate. Responsible for conducting the most complex global clinical research quality inspections across therapeutic areas and development phases.
• Expert in assessing quality systems, processes, and risk management relative to GCP, GVP, GLP, and GMP regulations
• Developed and executed innovative inspection techniques including remote regulatory assessments.
• Conducted joint regulatory inspections with regulators from Health Canada, the European Medicines Agency, and India's GLP Monitoring Authority
• Developed and delivered training on investigative techniques to FDA and international regulators and industry on Good Clinical Practice (GCP) and inspection readiness.
• Participated in working groups focused on elevating the skill level of Bioresearch Monitoring investigators, fostering collaboration among team members, and improving the efficiency and quality of our audits.
• Delivered timely and compelling inspection reports integral to FDA decisions on drug, device, biologics, and tobacco applications.
• Mentored new team members to build investigative skills, data integrity detection, and evidence development.

• FDA investigator with a focus on bioresearch monitoring, blood banking, plasma, and human cellular and tissue based product (HCTP) inspections. Additional experience with drug GMP inspections and investigations.
• Conducted in depth inspections requiring the application of regulations across multiple FDA product areas.
• Prepared detailed reports supporting regulatory decisions and actions based on extensive interviews, data review, and physical evidence.
• Trained and mentored new team members.
• Collaborated with other federal agencies on investigations.

Built and managed a private practice where I was responsible for all aspects of patient care, medical billing and business management. Marketed and sold the practice in 2008.