Senior Data Integrity Consultant
Dawar Consulting•San Diego, CA
•Onsite
About The Position
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.
Requirements
- 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
Nice To Haves
- Preferred experience in biotech, cell/gene therapy, or GMP manufacturing environments.
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
Benefits
- Medical
- Dental
- Vision
- Paid Sick leave
- 401K
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What This Job Offers
Job Type
Full-time
Career Level
Senior
