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POSITION SUMMARY
Oversee quality operations associated with CymaBay’s Commercial Programs ensuring company adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices, global (e.g., FDA, EMA, and PMDA) regulatory standards, and internal procedures and practices for manufacturing, testing and release activities of drug product in support of registration batch manufacturing, validation activities and commercial supply. Responsibilities include, but are not limited to, managing, leading, and coordinating resolution of quality related issues at CDMO/CMOs, review of GMP change controls, QA lot disposition, compilation of trending reports, writing quality investigations and assistance with product complaints investigations. |
ESSENTIAL DUTIES AND RESPONSIBILITIES
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MINIMUM QUALIFICATIONS
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The anticipated salary range for the position based in Newark, California is $195,000 - $225,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. CymaBay is a multi-state employer, and this salary range may not reflect the position outside of the Bay Area or in other states.
Full Time
Scientific Services
$173k-209k (estimate)
08/09/2023
04/26/2024
cymabay.com
NEWARK, CA
25 - 50
2017
YUNTAO SONG
<$5M
Scientific Services