Ajeena Robinson, Associate Director, Quality Assurance, is an experienced Quality Assurance and Compliance professional with over 10 years of experience in the biopharmaceutical and healthcare industries. With a strong focus on Contract Development and Manufacturing Organizations (CDMOs) and commercial manufacturing, Ajeena has extensive knowledge in drug product manufacturing, including fill-finish operations, as well as compliance with global regulations, including FDA, EU, Health Canada, ICH, ISO, and USP standards.
Ajeena has developed and managed quality assurance programs across all stages of product development, from pre-IND through Phase 4, and commercialization. She is highly skilled in conducting internal and external audits, ensuring adherence to Good Manufacturing Practices (GMP), and providing guidance on quality management systems, regulatory compliance, and inspection readiness. Her experience also includes overseeing vendor management programs, authoring standard operating procedures (SOPs), and leading continuous improvement initiatives to enhance overall quality standards and compliance.
Before joining Premier Consulting, Ajeena held various leadership roles in Quality Assurance, where she led cross-functional teams and successfully managed quality systems, audits, and training programs.