Sapan Patel Associate Director, Quality Assurance, AstraZeneca

Sapan Patel is a seasoned quality assurance leader with extensive expertise in the pharmaceutical and biopharmaceutical sectors, currently positioned as Associate Director QA at AstraZeneca. Fluent in multiple languages including Hindi, Gujarati, English, and Spanish, he brings a multicultural and inclusive perspective to his leadership roles. Based in Gaithersburg, Maryland, Sapan has demonstrated a robust ability to lead quality initiatives across various operational and strategic levels.

Holding a Master of Science in Pharmaceutical Manufacturing from Stevens Institute of Technology and a Bachelor of Science in Pharmacy from Rajiv Gandhi University of Health Sciences, Sapan has developed a solid foundation in drug development and manufacturing. His career includes significant stints at MilliporeSigma and MedImmune, where he led numerous quality improvement projects, demonstrating his capabilities in cross-functional team leadership and regulatory compliance.

Sapan's professional skills are vast, encompassing regulatory affairs, process validation, cleaning validation, and a proficiency in using Minitab for statistical analysis. His core areas of expertise include talent development, process transfer, scale-up initiatives, and process improvement, with a strong emphasis on employing Quality Risk Management (QRM) to make informed, risk-based decisions.

At AstraZeneca, Sapan has been instrumental in enhancing product quality leadership, focusing on strategic quality decision-making and improvement. His leadership extends to teaching and mentoring, preparing the next generation of quality professionals for future challenges in the industry.