BridgeBio Pharma
QA Operations - Drug Product, QA Manager
San Francisco - 1800 Owens · Full-time
Sponsorship not specified$150k-$175kDetected 14 days ago
A/B TestingGMPFDA RegulatoryResearchCommunicationCollaborationOrganizational SkillsGxP
About the role
- Mavericks Wanted When was the last time you achieved the impossible?
- Together we define white space, push boundaries, and empower people to solve problems.
- Together, we'll ask "why not?" and help reengineer the future of biopharma.
Responsibilities
- Manage quality oversight at Drug Product Contract Manufacturing Organizations (CMOs).
- Act as QA operations lead with assigned CMOs, including review of manufacturing batch records and batch release certificates.
- 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
- Support review of regulatory filings
- Support audit of CMOs
- This model allows science and small teams of experts to lead the way.
- We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
- Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail
Requirements
- 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
Compensation
- $150,000 - $175,000 USD
- Market-leading compensation
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Benefits
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Health & Well-Being
- As a global company, our comprehensive benefits may vary based on location.
Company info
- At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
Apply directly at BridgeBio Pharma →Create a free account for alerts like thisView BridgeBio Pharma immigration profile
This listing is sourced directly from BridgeBio Pharma's careers page and normalized into a canonical job model.