BridgeBio

2 weeks ago

Manager, Quality Systems and Risk Management

✓ 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

Own and drive the company’s formal risk management and Quality Management System (QMS) in a GxP biopharmaceutical environment. Lead risk assessments, maintain risk registers, and apply ICH Q9 and FMEA frameworks, while supporting QMS maintenance and continuous improvement. Manage Annual Product Quality Review (APQR) compilation, generate quality metrics and KPIs for QMRs, support process improvement (Lean Six Sigma and CAPA), and help ensure compliance through audits, inspections, and SOP updates.

Location: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Own and drive formal risk management activities by leading risk assessments, maintaining risk registers, and applying ICH Q9 and FMEA frameworks.
•Support maintenance and continuous improvement of the QMS, including onboarding and implementing new Veeva Vault QMS modules and maintaining procedural documentation.
•Manage preparation and compilation of APQR reports, supporting cross-functional data collection and timely completion and approval.
•Generate quality metrics and KPIs for QMRs; analyze and present quality data to identify trends, risks, and improvement opportunities.
•Support process improvement initiatives using Lean Six Sigma principles, including root cause analysis support and CAPA follow-through, and participate in audits/inspections to ensure GxP compliance.

Pay and Benefits

Salary: USD 126,400 - 152,700 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVision401kEquityParental Leave

Key Requirements

•Bachelor’s degree or equivalent in pharmacy, science, mathematics or engineering.
•Minimum 8 years’ experience in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field.
•Strong experience leading formal risk management in a GxP environment, using tools such as FMEA, risk ranking, and ICH Q9.
•Knowledge of Lean Six Sigma methodologies or equivalent (preferred).
•Knowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP) and proficiency in eQMS (preferably Veeva) plus Microsoft Office/Excel and Google Docs.

Experience:8+ yearsBiotechPharmaceuticalFDA-regulatedGxPCommercial-stage biopharmaceutical

Education:Bachelor's in pharmacy, science, mathematics or engineering

Skills:Detail-orientedAnalyticalProblem-solvingProject managementCollaboration

Languages:English

Tech Stack:ICH Q9FMEARisk registersQMSGxPAnnual Product Quality Review (APQR)Quality Management Reviews (QMRs)Veeva Vault QMSEQMSLean Six SigmaCAPAStandard Operating Procedures (SOPs)FDAEU GMPGDPMicrosoft OfficeExcelGoogle Docs

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

Manager, Quality Systems and Risk Management

✓ 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: United States

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Own and drive formal risk management activities by leading risk assessments, maintaining risk registers, and applying ICH Q9 and FMEA frameworks.
•Support maintenance and continuous improvement of the QMS, including onboarding and implementing new Veeva Vault QMS modules and maintaining procedural documentation.
•Manage preparation and compilation of APQR reports, supporting cross-functional data collection and timely completion and approval.
•Generate quality metrics and KPIs for QMRs; analyze and present quality data to identify trends, risks, and improvement opportunities.
•Support process improvement initiatives using Lean Six Sigma principles, including root cause analysis support and CAPA follow-through, and participate in audits/inspections to ensure GxP compliance.

Pay and Benefits

Salary: USD 126,400 - 152,700 annually

Equity and Bonus:Equity

Perks:Health InsuranceDentalVision401kEquityParental Leave

Key Requirements

•Bachelor’s degree or equivalent in pharmacy, science, mathematics or engineering.
•Minimum 8 years’ experience in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field.
•Strong experience leading formal risk management in a GxP environment, using tools such as FMEA, risk ranking, and ICH Q9.
•Knowledge of Lean Six Sigma methodologies or equivalent (preferred).
•Knowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP) and proficiency in eQMS (preferably Veeva) plus Microsoft Office/Excel and Google Docs.

Experience:8+ yearsBiotechPharmaceuticalFDA-regulatedGxPCommercial-stage biopharmaceutical

Education:Bachelor's in pharmacy, science, mathematics or engineering

Skills:Detail-orientedAnalyticalProblem-solvingProject managementCollaboration

Languages:English

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