Sr. Manager, QA Operations - Product Release
BridgeBio
3 months ago
Remote friendly (San Francisco, CA)
United States
$160,200 - $185,500 USD yearly
Operations
Responsibilities:
- Manage lot release activities at assigned Contract Manufacturing Organizations (CMOs) as QA Operations lead, including review of manufacturing batch records, certificates of analysis, and issuance of certificates of compliance
- Ensure CMO SOPs and Master Batch Records comply with cGMPs
- Serve as technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates
- Represent QA Operations on internal/external project teams, audits and inspections, and monitor CMO performance
- Review and manage master and executed manufacturing batch records and related documentation (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 Substance (DS), Drug Product (DP) and Finished Product (FP)
- Communicate/escalate manufacturing deficiencies and non-conformances; work with CMOs to ensure timely resolution
- Support review of regulatory filings
- Support audit of CMOs
Qualifications:
- Bachelor’s degree in a science discipline and 8+ years of experience in a biopharmaceutical company or contract research organization
- Strong knowledge of GMP, SOPs, and Quality Systems (e.g., Lot Release, Deviation, Change Control, CAPA), plus ICH and GxP principles
- General knowledge of FDA and other global clinical trial regulations
- Prior experience in QC, Analytical Development, and process validation (highly desired)
Skills/Requirements:
- Excellent verbal and written communication skills with strong customer focus
- Excellent organizational skills; ability to manage multiple tasks/competing priorities and maintain meticulous attention to detail
- Travel up to 10% total time
- Demonstrated curiosity and adaptability in adopting AI-powered tools and technologies
Where You’ll Work:
- Hybrid role: in-office collaboration 2–3x/week in San Francisco, or U.S.-based remote with quarterly/as-needed visits to San Francisco
- Manage lot release activities at assigned Contract Manufacturing Organizations (CMOs) as QA Operations lead, including review of manufacturing batch records, certificates of analysis, and issuance of certificates of compliance
- Ensure CMO SOPs and Master Batch Records comply with cGMPs
- Serve as technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates
- Represent QA Operations on internal/external project teams, audits and inspections, and monitor CMO performance
- Review and manage master and executed manufacturing batch records and related documentation (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 Substance (DS), Drug Product (DP) and Finished Product (FP)
- Communicate/escalate manufacturing deficiencies and non-conformances; work with CMOs to ensure timely resolution
- Support review of regulatory filings
- Support audit of CMOs
Qualifications:
- Bachelor’s degree in a science discipline and 8+ years of experience in a biopharmaceutical company or contract research organization
- Strong knowledge of GMP, SOPs, and Quality Systems (e.g., Lot Release, Deviation, Change Control, CAPA), plus ICH and GxP principles
- General knowledge of FDA and other global clinical trial regulations
- Prior experience in QC, Analytical Development, and process validation (highly desired)
Skills/Requirements:
- Excellent verbal and written communication skills with strong customer focus
- Excellent organizational skills; ability to manage multiple tasks/competing priorities and maintain meticulous attention to detail
- Travel up to 10% total time
- Demonstrated curiosity and adaptability in adopting AI-powered tools and technologies
Where You’ll Work:
- Hybrid role: in-office collaboration 2–3x/week in San Francisco, or U.S.-based remote with quarterly/as-needed visits to San Francisco