Biology, Biotech and Pharmaceutical, Change Control, Code of Federal Regulations, Computer Science, Computer Systems, Consulting, Data Quality, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Gene Therapy, GxP, Laboratory Systems, Maintain Compliance, Manufacturing, Manufacturing Software, Manufacturing Systems, Process Validation, QA Partner Testing Software, Quality Control, Risk Analysis, System Validation, United States Department of Energy (DOE), Validation Documentation
LOCATION
San Diego, California
POSTED
30+ days ago
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 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.
If interested, please send us your updated resume at