Michael M. has extensive work experience in the field of quality operations and engineering. Michael is currently serving as the Senior Director of Quality Operations and Engineering at Akebia Therapeutics since July 2022. Prior to this, they worked as the Director of Quality Engineering at the same company from June 2021 to October 2022.
Before joining Akebia Therapeutics, Michael worked as the Senior Quality Assurance Manager at Sterling Pharma Solutions from December 2019 to May 2021.
From December 2017 to December 2019, Michael held the position of Associate Manager, Quality Engineering at Sage Products, now part of Stryker. In this role, they managed and developed a team of Quality Engineers, provided support for audits, and assisted with regulatory responses. Michael also contributed to corporate integration activities and strategic process improvements. Prior to this, they served as a Senior Quality Engineer and Quality Engineer at the same company.
Additionally, Michael has experience working at Baxalta and Baxter International Inc. as a Quality Associate II, where they supported various quality systems and executed corrective and preventative actions.
Overall, Michael has comprehensive experience in quality operations and engineering, with a focus on pharmaceutical and medical device products. Michael has demonstrated leadership skills, participated in audits, and contributed to process improvements and regulatory compliance.
Michael M. obtained a Bachelor of Science (B.S.) degree in Chemical Science from Florida State University, where they studied from 2007 to 2009. In addition, they have obtained several certifications including: Manager of Quality/Organizational Excellence from ASQ - World Headquarters in November 2017, Quality Management System Lead Auditor (ISO9001:2015 & ISO13485:2016) from Exemplar Global, Inc. in May 2017, and Certified Quality Engineer from ASQ in June 2016.
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