QA Operations - Drug Product, QA Manager
BridgeBio
August 21, 2026
Remote friendly (San Francisco, CA)
United States
Operations
What You'll Do
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. Ensure CMO SOPs and Master Batch Records comply with cGMPs and provide technical review for deviations, change records, protocols, and CAPAs.
Responsibilities
- Represent QA Operations on internal/external project teams, audits/inspections, and monitor CMO performance
- Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents (specifications, analytical/micro methods, stability study/protocols, process/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 and work with CMOs for timely resolution
- Support review of regulatory filings
- Support audit of CMOs
Who You Are
- Bachelor’s degree in a science discipline with 8+ years in a biopharmaceutical company or CRO
- Strong knowledge of GMP, SOPs, Quality Systems (Lot Release, Deviation, Change Control, CAPA), ICH, and GxP
- Strong knowledge of FDA and other clinical trial regulations
- QC, Analytical Development, and process validation experience highly desired
- Excellent verbal/written communication and customer focus
- Strong organization, ability to manage multiple priorities, and attention to detail
- Travel up to 10%
Where You'll Work
In-office collaboration 2–3x per week in San Francisco.
Benefits (Financial & Rewards / Health)
- Base pay: $150,000–$175,000 (California range)
- 401(k) match, ESPP, pre-tax commuter benefits, referral bonus, subsidized lunch/parking
- 100% employer-paid medical/dental/vision, HSA (employer contributions), FSA, fertility/family-forming benefits, mental health support, flexible hybrid model, PTO, paid medical/parental leave
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. Ensure CMO SOPs and Master Batch Records comply with cGMPs and provide technical review for deviations, change records, protocols, and CAPAs.
Responsibilities
- Represent QA Operations on internal/external project teams, audits/inspections, and monitor CMO performance
- Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents (specifications, analytical/micro methods, stability study/protocols, process/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 and work with CMOs for timely resolution
- Support review of regulatory filings
- Support audit of CMOs
Who You Are
- Bachelor’s degree in a science discipline with 8+ years in a biopharmaceutical company or CRO
- Strong knowledge of GMP, SOPs, Quality Systems (Lot Release, Deviation, Change Control, CAPA), ICH, and GxP
- Strong knowledge of FDA and other clinical trial regulations
- QC, Analytical Development, and process validation experience highly desired
- Excellent verbal/written communication and customer focus
- Strong organization, ability to manage multiple priorities, and attention to detail
- Travel up to 10%
Where You'll Work
In-office collaboration 2–3x per week in San Francisco.
Benefits (Financial & Rewards / Health)
- Base pay: $150,000–$175,000 (California range)
- 401(k) match, ESPP, pre-tax commuter benefits, referral bonus, subsidized lunch/parking
- 100% employer-paid medical/dental/vision, HSA (employer contributions), FSA, fertility/family-forming benefits, mental health support, flexible hybrid model, PTO, paid medical/parental leave