James Miller
Quality Assurance (Qa) Manager @Cymabay Therapeutics
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WORK HISTORY
Quality Assurance (Qa) Manager @Cymabay Therapeutics
San Francisco, CA, US
Oversee quality operations associated with clinical programs and ensure quality compliance at contract manufacturing organizations (CMOs) and contract research organizations (CROs)Efficient management of all drug substance and finished product manufacturing and packaging activities at CMOs and CROsCollaboration with CMC Core Management Team to ensure conformance with project timelines as well a successful new drug application (NDA) submissionAssessment and approval of standard operating procedures (SOPs); master batch records; test methods, investigations into manufacturing and laboratory deviations; and specifications for drug substances, packaging materials, and finished products
EDUCATION
California State University - East Bay
Bachelor of Science - BS, Biology/Biological Sciences, General
SKILLS
ABOUT JAMES MILLER
James Miller is an analytical, goal-oriented, and performance-focused professional with more than 12 years of experience in the pharmaceutical industry focusing on quality assurance and quality control. He is a hands-on leader who is a proven expert in developing and implementing cost-effective strategies, and utilizing manufacturing technologies and processes toward operational efficiency and productivity while maintaining quality. James possesses extensive knowledge of industry standards, including Code of Federal Regulations (CFR), Food and Drug Administration (FDA), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations in relation to drug development and manufacturing.James’ extensive experience in the pharmaceutical industry has allowed him to earn several commendations throughout his career—which simply inspired him to improve further. Due to his exemplary efforts, dedication, and performance, James has consistently been promoted to positions with increasing responsibility. These include promotions from QA associate I to QA associate II, QA associate II to QA supervisor, and finally from QA supervisor to QA Manager. These successive promotions speak of his consistency in providing notable contributions and exceeding the expectations of the organization.
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