Profile

Akanksha is a seasoned clinical research professional with over 14 years of experience and a strong focus on Quality Management. Her career spans multiple facets of the clinical research landscape, having worked across Sponsors, CROs, and SMOs. She has held key roles in esteemed pharmaceutical companies and CROs,including AstraZeneca, Glenmark, and IQVIA. Most recently, Akanksha served as the Clinical Quality Director at AstraZeneca, where she led the India-based Quality Management team. In January 2024, she founded AJ Consulting – Quality Simplified, an organization that delivers specialized Quality
Management and Training solutions.

The consultancy focuses on conducting audits and
providing applied training in clinical research. As an experienced Auditor, Akanksha has conducted various audits, including Investigator Site Audits (ISAs), Vendor Audits, and Process Audits. As a Subject Matter Expert in
Quality Management Systems (QMS), she has developed and implemented QMS frameworks, standard operating procedures (SOPs), policies, and work instructions, along
with performing in-depth process gap analyses.Her leadership extends to overseeing serious Breach assessments, Critical Quality Issue management, and Ethics & Misconduct investigations.

She has been instrumental in advising sponsors on Corrective and Preventive Actions (CAPA) during issue reporting and in response to audit or inspection findings.
Currently based in both Tanzania and India, Akanksha offers her consulting services globally, helping organizations strengthen their quality frameworks and maintain compliance excellence in clinical research.