Niraj Patel
( Aspire Pharmaceutical )
I am a pharmaceutical executive with 17+ years of diversified experience in Quality Management, Laboratory operations, and Regulatory compliance. Currently, I serve as the Sr. Director of Quality and Regulatory with Aspire Pharmaceuticals , where I recently led initiatives to successfully move the site from an FDA Official Action Indicated (OAI) to a Voluntary Action Indicated (VAI) status. Throughout my career, which includes roles as Site Head of Quality for both Kashiv BioSciences and Cambrex , I have focused on driving operational excellence and transforming organizational compliance cultures. My educational background includes an MBA , an MS in Pharmaceutical Manufacturing , and a Bachelor of Pharmacy. I am deeply committed to establishing data-driven environments and leading continuous improvement initiatives across the pharmaceutical industry