QA Operations - Drug Product, QA Manager

Responsibilities

• Manage quality oversight at Drug Product Contract Manufacturing Organizations (CMOs)
• Act as the QA operations lead for assigned CMOs, including review of manufacturing batch records and batch release certificates
• Ensure CMO SOPs and Master Batch Records comply with cGMPs
• Perform technical review for deviations, change records, protocols, and CAPAs
• Represent QA Operations on internal and external project teams, audits, and inspections
• Author and perform quality review of SOPs and quality events (OOS/OOT, change controls, etc.)
• Lead the disposition of Drug Product
• Communicate and escalate manufacturing deficiencies to management and work with CMOs on resolution
• Support regulatory filings and CMO audits

Requirements

• Bachelor's Degree in a science discipline
• 8+ years of experience within a biopharmaceutical company or contract research organization (CRO)
• Strong knowledge of GMP, SOPs, and Quality Systems (Lot Release, Deviation, Change Control, CAPA)
• Deep understanding of ICH and GxP principles
• Strong knowledge of FDA and clinical trial regulations
• Excellent verbal and written communication skills
• Ability to manage multiple tasks and maintain meticulous attention to detail
• Willingness to travel up to 10%

Preferred Qualifications

• Prior experience in Quality Control (QC), Analytical Development, or process validation

Benefits

• Market-leading compensation and annual performance bonus
• 401(k) with employer match and Employee Stock Purchase Program (ESPP)
• 100% employer-paid medical, dental, and vision premiums for employees and dependents
• Flexible, “take-what-you-need” paid time off and comprehensive parental leave
• Hybrid work model with in-office collaboration in San Francisco 2-3x per week
• Professional development via LinkedIn Learning, LifeLabs, and coaching

About the Company

BridgeBio is a biopharmaceutical company that uses a unique model to pool projects and early-stage research to reduce risk and accelerate innovation. We build bridges to groundbreaking advancements in rare diseases, developing life-changing medicines for patients with unmet needs as fast as humanly possible.