Manager, QA Operations

About the Role: BridgeBio is a pioneer in a "moneyball for biotech" approach, working to reengineer the future of biopharma. We are looking for a Manager/Senior Manager, QA Operations to serve as the primary quality owner for commercial packaging operations at assigned contract service providers (CSPs). You will ensure GMP compliance, manage batch record review, and partner with stakeholders to drive quality and innovation.

What You'll Do

• Serve as the quality lead for commercial packaging operations at assigned CSPs, ensuring GMP and GDP compliance.
• Review executed batch records and compile documentation packages to support lot disposition and market release.
• Review deviations, change controls, CAPAs, and risk assessments related to packaging operations.
• Communicate and escalate manufacturing deficiencies to management and work with CMOs for timely resolution.
• Author, review, and maintain QA Operations SOPs and controlled documents.

What You Bring

• Bachelor's degree in a scientific discipline with 6+ years of biopharmaceutical experience.
• 4+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment.
• Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations.
• Experience with the Veeva platform is highly preferred.
• Up to 15% domestic and international travel required.

Benefits

• Annual salary range: $135,700 - $175,000 USD.
• 100% employer-paid medical, dental, and vision premiums for you and your dependents.
• 401(k) with employer match, Employee Stock Purchase Program (ESPP), and comprehensive paid leave.
• Hybrid work model with flexibility (U.S.-based remote role requiring quarterly visits to the San Francisco office).