Job Description
Job DescriptionOur 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 hr@dawarconsulting.com/lakshmi@dawarconsulting.com