QA Consultant (QMS/GxP)

Job Description
Our client, a world leader in biotechnology and life sciences, is looking for a "QA Consultant" based out of San Diego, CA.
Job Duration: Long Term Contract (Possibility Of Extension)

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K
We are seeking an experienced QA Consultant (GxP) to support and enhance Quality Systems at a clinical-stage biotech facility focused on cell and gene therapies. The role will oversee Quality Management 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 system migration.
• Manage GxP quality processes including Change Control, Deviations, CAPA, Training, and Document Control.
• Provide oversight for SOP updates, quality documentation, and document lifecycle management.
• Monitor quality metrics and dashboards to maintain compliance.
• Support EDMS/LMS systems such as Qualio and ComplianceWire.
• Assist with internal/external audits and corrective action plans.
• Collaborate cross-functionally with QA, QC, Manufacturing, Validation, Supply Chain, and Clinical teams.

Qualifications:
• Bachelor's degree in Life Sciences or related field.
• 8+ years of QA experience in GxP environments (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 and quality documentation.

If interested, please send us your updated resume at

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Skill Set
QMS, SOP, CAPA