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Senior Data Integrity Consultant

Dawar Consulting, Inc.

Job Location:

San Diego, CA - USA

Monthly Salary: Not provided by the employer

Posted: 24 May 2026 (30+ days ago)

Application Deadline: 21 August 2026

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

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

Bachelors 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.