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Senior Manager, Computer System Validation QA

4 hours, 9 minutes ago
United States
Full-time
Lead
Manual QA Tester
Quality Assurance and Testing
GCP
Apply Now
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised
View All Jobs 7

Description

  • Provide QA oversight across the GCP/GVP computer system validation lifecycle, from design and configuration through maintenance and retirement.
  • Review and approve system risk assessments, change controls, validation protocols, test scripts, and reports.
  • Participate in periodic system and user reviews and remediate compliance gaps.
  • Partner with IT, Quality Assurance, system owners, business process owners, and service providers on validation, data integrity, and system maintenance requirements.
  • Support computer system audits, including audit report and CAPA reviews.
  • Project-manage implementation, configuration, and enhancement of GCP/GVP and QMS computer systems.
  • Drive continuous improvement for QMS and validated GxP systems.
  • Support inspection readiness, regulatory inspections, response management, and CAPA closure as a QA CSV subject matter expert.
  • Review and approve GxP system and business-process procedures and support end-user compliance training.
  • Represent GCP/GVP Quality in organizational AI governance activities.

Requirements

  • Bachelor’s or master’s degree in software, computer engineering, or a related technical field.
  • 8+ years of quality systems development and maintenance experience in clinical- or commercial-stage pharmaceutical or biotech companies.
  • Demonstrated expertise in GxP computerized system validation/assurance (CSV/CSA) and system lifecycle management.
  • Working knowledge of 21 CFR Part 11, FDA predicate rules, EU Annex 11, ICH GCP, EU GVP, and risk-based practices such as GAMP.
  • Experience developing GxP SOPs and training personnel on compliance requirements.
  • Strong attention to detail, organization, written and verbal communication skills.
  • Ability to work independently, collaborate effectively, and influence cross-functional teams.
  • Experience with AI/large language models and AI governance in a GxP setting is preferred.
  • Remote employees must travel to the San Francisco office quarterly.

Benefits

  • California salary range of $145,000–$170,000, plus annual performance bonus and company equity.
  • Market-leading compensation, 401(k) with employer match, and employee stock purchase program.
  • 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • HSA with employer contributions, FSA, fertility and family-forming benefits, and paid medical and parental leave.
  • Hybrid work model, flexible paid time off, and company-paid holidays.
  • Mental health support through therapy and coaching resources.
  • Pre-tax commuter benefits, subsidized lunch and parking on in-office days.
  • Professional development, coaching, career pathing, and internal mobility opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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