Senior QA Lead, Drug Product Operations

BridgeBio Inc.; San Francisco (CA); Hybrid; USD 150,000 - 175,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Hybrid work model

100% employer-paid medical, dental, et

Vision premiums for you and dependents

Job summary

BridgeBio Inc. in San Francisco is seeking a QA Operations - Drug Product, QA Manager to lead quality oversight at Drug Product CMOs and ensure cGMP compliance across batch release and related activities.

You will review manufacturing records, author SOPs and CAPAs, and coordinate with CMOs to resolve quality findings. The role requires 8+ years in biopharma with GMP expertise and strong communication skills. Hybrid in-office presence 2–3 days/week in SF.

Qualifications

• 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

Responsibilities

• 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 (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.)
• 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

Skills

GMP knowledge

SOPs

Quality Systems

FDA regulations

QC experience

Analytical development

Excellent communication

Organizational skills

Education

Bachelor's Degree in science

Job description

BridgeBio Inc. in San Francisco is seeking a QA Operations - Drug Product, QA Manager to lead quality oversight at Drug Product CMOs and ensure cGMP compliance across batch release and related activities.

You will review manufacturing records, author SOPs and CAPAs, and coordinate with CMOs to resolve quality findings. The role requires 8+ years in biopharma with GMP expertise and strong communication skills. Hybrid in-office presence 2–3 days/week in SF.