Senior Manager, Computer System Validation QA

BridgeBio
United States
Workplace: RemoteFull timeUSD 145,000 - 170,000 annuallyFunction: QA, Test & Release EngineeringExperience: 8+ yearsEducation: bachelorsSkills: ["Attention to detail","Organizational skills","Written communication","Verbal communication","Cross-functional influence"]

Provide QA oversight for the end-to-end computer system validation lifecycle for GCP/GVP computerized systems, ensuring ongoing compliance and a validated state. Review and approve risk assessments, validation deliverables, periodic system/user reviews, and IT change control. Partner with IT and GMP Quality stakeholders to enforce requirements for validation, data integrity, and maintenance. Support audits, CAPA, inspection readiness, and AI governance as the GCP/GVP Quality representative.

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FursaFursa
BridgeBio
BridgeBio
12 hours ago

Senior Manager, Computer System Validation QA

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Last checked: 2 hours agoStatus: Live

Job Summary

Provide QA oversight for the end-to-end computer system validation lifecycle for GCP/GVP computerized systems, ensuring ongoing compliance and a validated state. Review and approve risk assessments, validation deliverables, periodic system/user reviews, and IT change control. Partner with IT and GMP Quality stakeholders to enforce requirements for validation, data integrity, and maintenance. Support audits, CAPA, inspection readiness, and AI governance as the GCP/GVP Quality representative.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Sr. Manager level

Key Responsibilities

  • •Provide QA oversight of the GCP/GVP computer system validation lifecycle, ensuring ongoing compliance from design and configuration through maintenance.
  • •Review and approve computer system risk assessments, validation deliverables (protocols, test scripts, and reports), and IT change control/validation outcomes.
  • •Participate in periodic system and user reviews to identify and remediate compliance gaps.
  • •Support audit program activities, including audit report reviews and CAPA reviews, and manage CAPA response/closure through timely resolution.
  • •Project manage implementation and continuous enhancement of GCP/GVP and QMS computer systems; support inspection readiness and end-user training for proper adoption and compliance.

Pay and Benefits

Salary: USD 145,000 - 170,000 annually
Equity and Bonus:Equity
Perks:401kEsppHealth InsuranceDentalVisionHsaFsaParental LeavePaid LeaveRemote Work

Key Requirements

  • •Bachelor’s or Master’s degree in software, computer engineering, or a technical field.
  • •8+ years of experience in quality systems development and maintenance in clinical and commercial-stage pharmaceutical or biotech companies.
  • •Demonstrated expertise in GxP computerized system validation/assurance (CSV/CSA) and system lifecycle management.
  • •Working knowledge of electronic records, computerized systems, and data integrity requirements, including 21 CFR Part 11, EU Annex 11, ICH GCP, and EU GVP.
  • •Experience developing GxP SOPs and training personnel on compliance requirements.
Experience:8+ yearsPharmaceuticalBiotechGxPClinicalData integrity
Education:Bachelor's in software, computer engineering, or technical field
Skills:Attention to detailOrganizational skillsWritten communicationVerbal communicationCross-functional influence
Languages:English
Tech Stack:GxPCSVCSAQMS21 CFR Part 11EU Annex 11ICH GCPEU GVPGAMPAI governanceLLMs

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