p>Provide end-to-end Quality support for the manufacture of mid-phase through Commercial gene therapies, oncolytics, vaccines, immunotherapies, or other biological products under the regulatory purview of current Good Manufacturing Practices (21 CFR Parts 210/211, 600, and 610); to include, but not limited to, the following: o Review and approve master batch records, material specifications, quality control test methods/validations, raw material inspection and release packets, environmental monitoring data, and any other documentation associated with the development, execution, and review/approval of manufactures for product release. This role partners closely with Manufacturing, Quality Control, and cross-functional teams to ensure compliance with FDA, EU, and ICH regulatory requirements while supporting product disposition, batch record review, investigations, CAPAs, change controls, audits, and continuous improvement initiatives.