Senior Data Integrity Consultant

Our client, a world leader in biotechnology and life sciences, is looking for a Senior Data Integrity Consultant based out of San Diego, CA. 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 au...