Michael Brinkley

Chief Quality Officer at PAI Pharma

Michael Brinkley, MBA, CQA, CQM, CCRA has over 20 years of experience in the pharmaceutical industry. Michael is currently the Chief Quality Officer at PAI Pharma, where they are responsible for quality and DEA compliance. Prior to their current role, they served as the Vice President of Quality at Wockhardt USA and Endocyte, Inc. At Endocyte, Inc, Michael was a member of the senior leadership team and played a key role in transitioning quality systems from development to commercial operations. Michael also served as the Director of Quality Assurance at JHP Pharmaceuticals LLC and Vice President of Quality and Compliance at Boehringer Ingelheim. Michael has a strong background in quality control and has successfully led teams and implemented lean six sigma projects.

Michael Brinkley holds a Bachelor of Science degree in Microbiology from North Carolina State University, which they obtained from 1983 to 1986. Michael later pursued an MBA in Global Management from UNC Kenan-Flagler Business School, completing it in 2011. Michael has received various certifications including Certified Manager of Quality/Organizational Excellence from ASQ in June 2016, Certified Clinical Research Associate from the Association of Clinical Research Professionals in February 2016, Certified Quality Auditor from ASQ in December 2015, and ASQ Certified Quality Auditor from ASQ - World Headquarters in November 2015. In 2017, they also received a Certificate of Attendance - European Clinical Quality Oversight Forum from ExL Events, Inc. Michael Brinkley is also a Certified Clinical Auditor, although the specific details of this certification are not provided.

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