QA Consultant (QMS/GxP)

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

[email protected]/[email protected]