Quality Consultant and GxP Maven with 10+ years’ Experience

Seasoned and driven Clinical QA and cGxP Regulatory Maven is well adept in the application of U.S federal and international regulations pertaining to the commercialization of global drugs, devices, and biologics.

Well-experienced in analyzing and troubleshooting problems and recommending the implementation of efficient risk management strategies.

Excellent attention to detail and coherency in the development of technical reports, clinical protocols, and SOPs. Proficient at responding to inquiries from federal executive management, stakeholders, and foreign regulatory agencies.