Senior Data Integrity Consultant

Senior Data Integrity Consultant (GxP) – On‑Site | San Diego, CAWe’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 DoLead and enhance the site’s Data Integrity programConduct DI gap assessments and drive remediation plansEnsure 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 recordsReview/approve validation deliverables (URS, RA, IQ/OQ/PQ, VSR, PSR)Support audits, inspection readiness, and system lifecycle governancePartner with technical SMEs to strengthen data flow, security, and system integration controlsWhat You BringBachelor’s in Life Sciences, Engineering, Computer Science, or related field8+ years in a GxP environment (biotech/pharma/cell & gene therapy preferred)Deep expertise in Data Integrity, CSV, and Quality ComplianceStrong knowledge of QMS processes (Change Control, Deviations, CAPA, Document Control, Training)Experience with EDMS, LMS, and lab/manufacturing systemsExcellent communication skills and ability to lead complex compliance initiatives