
Vaibhav Patel
Director of Quality Assurance and Regulatory Affairs
at University of Minnesota
Vaibhav Patel is a seasoned Quality Assurance professional with over 13 years of experience in drug development. As the director of quality assurance and regulatory affairs at the University of Minnesota, he excels in managing quality systems for clinical productions and ensuring FDA compliance. His career covers various biopharmaceutical domains, including radiopharmaceuticals, nanomedicine, cell and gene therapy products and monoclonal antibodies. Vaibhav's expertise includes developing phase-appropriate quality management systems, leading QA teams and managing IND product releases as well as managing CDMOs in the US, China and India. Previously, he held key roles at Elucida Oncology and Memorial Sloan-Kettering Cancer Center, where he was pivotal in implementing robust quality management systems. Vaibhav is a certified Quality Auditor and holds a Regulatory Affairs Certification. He actively contributes to the professional community through research and participation in organizations like the Society of Quality Assurance and Parenteral Drug Association. He holds a Master’s degree in Pharmaceutical Manufacturing from Stevens Institute of Technology and a Bachelor of Pharmacy from Rajiv Gandhi University of Health Sciences.
Areas of Expertise
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