Fariba Azizi, MS

With over 30 years of experience in the pharmaceutical industry and R&D, and more than 20 years specializing in clinical quality and GCP, Fariba brings deep expertise in global compliance, quality assurance, and clinical research operations. Her work spans a broad range of therapeutic areas, including Cardiology, Oncology, Central Nervous System (CNS), Diabetes, Immunology, Infectious Diseases, Vaccines, Dermatology, and Respiratory supporting Phase 1–4 clinical trials.

Fariba specializes in aligning complex clinical and laboratory quality systems with evolving global regulations, including GCP, GLP, GMP, ICH guidelines, and FDA requirements. Her experience includes developing and optimizing Standard Operating Procedures (SOPs), implementing audit strategies, and driving inspection readiness initiatives, including support for BIMO inspections.

Throughout her career, Fariba has held senior consulting and leadership roles, including serving as President of Azizi Pharmaceutical Services, where she oversaw QA infrastructure consulting, managed audit teams, and led regulatory inspection-readiness efforts. She has supported multiple organizations in building and enhancing Quality Management Systems (QMS), establishing vendor oversight frameworks, and leading cross-functional collaborations to identify compliance risks and implement effective Corrective and Preventive Actions (CAPAs).

Earlier in her career, Fariba built a strong technical foundation in analytical chemistry and GLP laboratory environments, contributing to pharmaceutical R&D through method development, stability testing, and validation of analytical systems.

Fariba is known for fostering collaboration across clinical, regulatory, and operational teams to deliver practical, scalable, and inspection-ready compliance solutions that improve quality outcomes and operational efficiency.