Sr. Mgr., Quality Management Systems

BridgeBio
United States
Workplace: RemoteFull timeUSD 147,700 - 176,500 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 7+ yearsEducation: bachelorsSkills: ["Cross-functional collaboration","Risk-based decision-making","Communication","Priority management","Quality governance"]

Lead the administration, governance, and continuous improvement of the company’s Quality Risk Management (QRM) program for GxP operations. Serve as a trained backup for Document Control and GxP Training, ensuring assigned QMS processes are compliant, inspection-ready, effective, and scalable. Partner with cross-functional teams to embed risk-based decision-making, maintain audit-ready documentation, oversee QMS workflows and KPIs, and support systems/digital quality initiatives including eQMS and Veeva quality tools.

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FursaFursa
BridgeBio
BridgeBio
4 days ago

Sr. Mgr., Quality Management Systems

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Last checked: 14 hours agoStatus: Live

Job Summary

Lead the administration, governance, and continuous improvement of the company’s Quality Risk Management (QRM) program for GxP operations. Serve as a trained backup for Document Control and GxP Training, ensuring assigned QMS processes are compliant, inspection-ready, effective, and scalable. Partner with cross-functional teams to embed risk-based decision-making, maintain audit-ready documentation, oversee QMS workflows and KPIs, and support systems/digital quality initiatives including eQMS and Veeva quality tools.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Sr. Director level

Key Responsibilities

  • •Lead the development, deployment, and continuous improvement of the QRM program, including procedures, templates, tools, and risk registers.
  • •Facilitate cross-functional risk assessments (e.g., risk ranking/filtering, hazard analysis, FMEA), ensuring risk owners, mitigation actions, due dates, residual-risk decisions, and reviews are defined and tracked.
  • •Serve as a trained backup for Document Control and GxP Training, including controlled-document workflows, training assignments, compliance monitoring, and inspection-ready record maintenance.
  • •Oversee assigned QMS workflows, author or revise quality procedures, monitor KPIs, and implement improvements to promote compliance, efficiency, and scalability.
  • •Maintain audit-ready QMS documentation and support audit/inspection preparation, response, and finding closure, collaborating across GMP, Clinical, CMC, Regulatory, and Supply Chain.
Travel: Low travel

Pay and Benefits

Salary: USD 147,700 - 176,500 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVision401kEquityPaid LeaveHsaFsa

Key Requirements

  • •Bachelor’s degree in a scientific or technical discipline, or equivalent relevant experience.
  • •Minimum of 7 years of progressive Quality Assurance or related experience in pharmaceutical or biotechnology.
  • •Experience building, deploying, and continuously improving a QRM program and facilitating cross-functional risk assessments in a GxP-regulated environment.
  • •Working knowledge of applicable GxP regulations and global regulatory expectations.
  • •Hands-on experience with Veeva Vault Quality applications (QualityDocs, Training, and QMS) and support for Document Control and GxP Training processes.
Experience:7+ yearsPharmaceuticalBiotechnology
Education:Bachelor's
Skills:Cross-functional collaborationRisk-based decision-makingCommunicationPriority managementQuality governance
Tech Stack:Veeva Vault QualityQualityDocsGxP TrainingEQMSQMSFMEAFMEA/risk assessmentsVeeva

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