South San Francisco, California, United States · On-site
$190k–$230k/yr
As the Director of GMP Quality, you will be responsible for leveraging your extensive knowledge to ensure the development, manufacturing, and release of products to support the advancement of JLSa2’s pipeline. This role …
Skills: GMP Quality Oversight, CDMO Management, Quality Management Systems, Regulatory Compliance, Audit Support
South San Francisco, California, United States • On-site
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Lead GMP quality oversight for the development, manufacturing, and release of drug substance and drug product. Manage compliance actions, CDMO vendors, and Quality Management Systems to ensure adherence to regulatory requirements.
Requires a bachelor's or advanced scientific degree and at least 5 years of GMP quality experience in biotechnology or pharmaceuticals. Must possess strong knowledge of cGMP regulations (21 CFR, EU GMP, ICH) and experience managing complex compliance challenges.
As the Director of GMP Quality, you will be responsible for leveraging your extensive knowledge to ensure the development, manufacturing, and release of products to support the advancement of JLSa2’s pipeline. This role will lead compliance actions in partnership with internal stakeholders and external vendors to reduce and resolve issues across GMP projects. This role will allow you to have a major impact on our mission to support our patients.
Salary Range: $190,000 to $230,000 (Compensation will be commensurate with experience/expertise/level and could fall outside of the stated range)
