Senior Manager, CSV Quality Assurance
Job Summary
To support the quality oversight of the computer system validation lifecycle, the remote Senior Manager, CSV Quality Assurance will manage compliance for GxP applications, collaborate cross-functionally with IT and business stakeholders, and drive continuous improvement initiatives.
Key responsibilities
- Provide QA oversight of the GCP/GVP computer system validation lifecycle, ensuring ongoing compliance and a validated state
- Review and approve computer system risk assessments and validation deliverables, including protocols and test scripts
- Support inspection readiness and regulatory activities, serving as a QA CSV subject matter expert
Required qualifications
- Bachelor's or Master's degree in software, computer engineering, or a technical field
- 8+ years of experience in quality systems development within clinical and commercial-stage pharmaceutical or biotech companies
- Demonstrated expertise in GxP computerized system validation/assurance and system lifecycle management
- Working knowledge of electronic-record and data-integrity requirements, including 21 CFR Part 11 and ICH GCP
- Experience with Artificial Intelligence (AI) governance in a GxP setting is a plus
Complete Job Description
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