Hiring: QA Operations - Drug Product, QA Manager Company: BridgeBio Location: San Francisco, CA Job Posted Time: 2026-09-12 11:47:39 Employment Type: Full-time / Hybrid About the job Experience: •8+ years of experience within a biopharmaceutical company, or contract research organization Required Skills: •Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance •Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports •Author and perform quality review of SOPs and quality events •Lead Disposition of Drug Product •Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution •Support review of regulatory filings •Support audit of CMOs •This role requires in-office collaboration 2-3x per week in our San Francisco office. Qualifications: •Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization •Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA,) ICH and GxP principles •Strong knowledge of FDA and other clinical trial regulations •Prior experience in QC, Analytical Development and process validation highly desired •Excellent verbal and written communication skills, with strong customer focus •Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail •Travel up to 10% total time Compensation: •$150,000 - $175,000 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!