Senior Data Integrity Consultant

Salary :

$85 - 92 hourly

Company : Dawar Consulting Inc

Job Type : Full Time

San Diego, United States

Job Description - 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 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 [email protected]/[email protected]

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Senior Data Integrity Consultant

Job Description - Senior Data Integrity Consultant

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