BridgeBio

2 weeks ago

QA Operations - Drug Product, QA Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours 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

Website LinkedIn

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BridgeBio

2 weeks ago

QA Operations - Drug Product, QA Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

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

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

Website LinkedIn