QA Consultant (QMS/GxP)
Dawar Consulting, Inc., San Diego, CA, United States
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr