Senior Data Integrity Consultant

Senior Data Integrity Consultant San Diego, United States | Posted on 05/19/2026 Job Duration: Long Term Contract (Possibility Of Extension) Pay Rate: $85/hr - $92/hr on W2 DOE Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Summary In this role, you will support Data Integrity (DI) and Computer System Validation (CSV) activities within a GMP-regulated biotech environment. And, you will provide Quality oversight for computerized systems, laboratory systems, manufacturing applications, and paper-based processes to ensure compliance with FDA and EU regulatory requirements. Responsibilities Lead Data Integrity governance and compliance activities Perform gap assessments, risk assessments, and remediation support Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles Review and support CSV deliverables including URS, IQ/OQ/PQ, risk assessments, and validation documentation Support audit readiness, periodic reviews, user access reviews, and change controls Partner with QA, QC, Manufacturing, Validation, and IT teams on GMP compliance initiatives Qualifications Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field 8+ years of GxP experience in pharmaceutical or biotech environments Strong experience in: Data Integrity Computer System Validation (CSV) GMP Quality Compliance Laboratory and Manufacturing Systems Strong knowledge of: FDA 21 CFR Part 11 EU Annex 11 GAMP 5 ALCOA+ principles Preferred experience in biotech, cell/gene therapy, or GMP manufacturing environments. #J-18808-Ljbffr