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Consultant Specialists, Inc. (CSI)
Senior Data Integrity Consultant

Senior Data Integrity Consultant

On site

San diego, United states

$ 85 /hour

Senior

Freelance

12-03-2026

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Skills

Communication Training

Job Specifications

Senior Data Integrity Consultant (GxP) – On‑Site | San Diego, CA

We’re looking for a seasoned Data Integrity (DI) and CSV expert to lead the development and oversight of our site’s Data Integrity program. This on‑site consulting role is central to ensuring the integrity, reliability, and compliance of data generated across our laboratory, manufacturing, and quality systems.

At our San Diego clinical‑stage biopharma site, you’ll help advance next‑generation cell and gene therapies designed to deliver potential single‑treatment cures for cancer and rare diseases.

What You’ll Do

Lead and enhance the site’s Data Integrity program
Conduct DI gap assessments and drive remediation plans
Ensure compliance with FDA 21 CFR Part 11/210/211/820, EU Annex 11, GAMP 5, ALCOA+
Provide QA oversight for computerized systems, QMS processes, and paper‑based GxP records
Review/approve validation deliverables (URS, RA, IQ/OQ/PQ, VSR, PSR)
Support audits, inspection readiness, and system lifecycle governance
Partner with technical SMEs to strengthen data flow, security, and system integration controls

What You Bring

Bachelor’s in Life Sciences, Engineering, Computer Science, or related field
8+ years in a GxP environment (biotech/pharma/cell & gene therapy preferred)
Deep expertise in Data Integrity, CSV, and Quality Compliance
Strong knowledge of QMS processes (Change Control, Deviations, CAPA, Document Control, Training)
Experience with EDMS, LMS, and lab/manufacturing systems
Excellent communication skills and ability to lead complex compliance initiatives

About the Company

Consultant Specialists, Inc. is a small, specialized firm, built and operated by staffing industry veterans with many years experience. We are a full-service technical staffing firm focused on providing technical consultants on a contract basis to companies San Francisco, San Jose and across Northern California. As a small firm, CSI is extremely flexible and fast while remaining cost competitive. Recruiting the best of the best gets more done in less time. That's why we rely on our comprehensive internal database, rather th... Know more