QA Operations - Drug Product, QA Manager

BridgeBio
San Francisco
Workplace: HybridFull timeUSD 150,000 - 175,000 annuallyFunction: QA, Test & Release EngineeringExperience: 8+ yearsEducation: bachelorsSkills: ["Communication","Organizational skills","Attention to detail","Customer focus","Managing competing priorities"]

Oversee quality operations for drug product manufacturing at Contract Manufacturing Organizations (CMOs). Serve as QA operations lead by reviewing batch records and release certificates, ensuring SOPs and Master Batch Records comply with cGMPs. Lead technical review of deviations, change records, protocols, and CAPAs, and author/perform quality reviews for quality events. Coordinate drug product disposition, support regulatory filings, and help monitor CMO performance through audits and inspections.

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BridgeBio
BridgeBio
2 months ago

QA Operations - Drug Product, QA Manager

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Last checked: 51 minutes agoStatus: Live

Job Summary

Oversee quality operations for drug product manufacturing at Contract Manufacturing Organizations (CMOs). Serve as QA operations lead by reviewing batch records and release certificates, ensuring SOPs and Master Batch Records comply with cGMPs. Lead technical review of deviations, change records, protocols, and CAPAs, and author/perform quality reviews for quality events. Coordinate drug product disposition, support regulatory filings, and help monitor CMO performance through audits and inspections.
Location: San Francisco
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Manager level

Key Responsibilities

  • •Manage quality oversight for drug product manufacturing at 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.
  • •Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications).
  • •Lead drug product disposition and communicate/escalate non-conformances to management, coordinating timely resolutions with CMOs.
  • •Support review of regulatory filings and support audits of CMOs, including monitoring of CMO performance.
Travel: Low travel

Pay and Benefits

Salary: USD 150,000 - 175,000 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVision401kEquityPaid LeaveParental Leave

Key Requirements

  • •Bachelor's degree in a science discipline with 8+ years of experience in 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 is highly desired.
  • •Excellent verbal and written communication with strong customer focus.
Experience:8+ yearsBiopharmaceuticalsContract research organizationsQCAnalytical developmentProcess validation
Education:Bachelor's
Skills:CommunicationOrganizational skillsAttention to detailCustomer focusManaging competing priorities
Languages:English
Tech Stack:CGMPGMPSOPsQuality SystemsLot ReleaseDeviationChange ControlCAPAICHGxPFDAOOSOOT

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn