QA Operations - Drug Product, QA Manager

Role: Quality Operations Lead for Drug Product at BridgeBio, overseeing CMO compliance and batch release activities. Responsibilities: manage quality review of manufacturing batch records, SOPs, deviations, CAPAs, and change controls; lead drug disposition; support audits and regulatory filings; represent QA in project teams and monitor CMO performance; escalate manufacturing issues as needed. Requirements: Bachelor's in a science discipline; 8+ years in biopharma or CRO; strong knowledge of GMP, GxP, FDA regulations; experience with QC, analytical development, or process validation preferred; excellent communication, organization, and attention to detail. HighValue: biologics or small molecule drug products, cGMP compliance, batch release, QA operations, regulatory support, pharma manufacturing oversight. WorkSetup: hybrid in San Francisco, 2-3 days onsite; travel up to 10%.