QA Consultant (QMS/GxP)

San Diego, United States | Posted on 03/12/2026

Company Benefits

Medical, Dental, Vision, Paid Sick leave,401K

We are seeking an experienced QA Consultant (GxP) tosupport and enhance Quality Systems at a clinical-stage biotech facilityfocused on cell and gene therapies .The role will oversee QualityManagement Systems (QMS), Document Control, EDMS, and GxP compliance ,while ensuring regulatory alignment and operational efficiency.

Key Responsibilities

• Support QMS integration and legacy system management during systemmigration.
• Manage GxP quality processes including Change Control, Deviations, CAPA,Training, and Document Control.
• Provide oversight for SOP updates, quality documentation, anddocument lifecycle management.
• Monitor quality metrics and dashboards to maintain compliance.
• Support EDMS/LMS systems such as Qualioand ComplianceWire.
• Assist with internal/external audits and corrective action plans.
• Collaborate cross-functionally with QA, QC, Manufacturing, Validation, SupplyChain, and Clinical teams.

Qualifications

• Bachelor’s degree in Life Sciencesor related field.
• 8+ years of QA experience in GxPenvironments (biotech, pharma, or cell/gene therapy).
• Strong knowledge of QMS, CAPA,Deviations, Change Control, and Document Control.
• Experience with EDMS/LMS systems(Qualio, ComplianceWire preferred).
• Ability to write/revise SOPs andquality documentation.

If interested, please send us your updated resume at

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