Data Integrity Program Lead
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Job Summary
To support the Data Integrity transformation initiative, the full-time Data Integrity Program Lead will manage assessments, strategy development, and governance implementation while collaborating with site stakeholders to enhance laboratory systems and compliance in a hybrid work environment.
Key responsibilities
- Conduct Data Integrity maturity and risk assessments, and develop remediation roadmaps
- Implement governance frameworks and strengthen Data Integrity controls across laboratory operations
- Facilitate collaboration among Quality, IT, and Laboratory Operations to improve inspection readiness
Required qualifications
- 10+ years of experience in pharmaceutical, biotechnology, or medical device industries
- 5+ years leading Data Integrity programs in GxP-regulated laboratories
- Proven experience in assessing Data Integrity maturity and executing remediation programs
- Familiarity with FDA and EU GMP Data Integrity guidelines
- Background in Quality Control or Analytical Development within laboratory settings
Complete Job Description
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