Quality & Compliance Manager, Computer System Validation

JOB SUMMARY

The Quality & Compliance Manager, Computer System Validation manages the quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations. The role partners with Quality, IT, system owners, operational teams, and external providers to ensure systems are fit for intended use, maintain data integrity, and remain compliant and inspection-ready from implementation through retirement. The Manager establishes consistent, risk-based computer system assurance practices and drives continuous improvement across clinical and laboratory environments.

 

MAIN DUTIES & RESPONSIBILITIES

• Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle, from initial assessment and implementation through operation, periodic review, significant change, and retirement.
• Review and approve applicable validation and assurance deliverables, including system risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, validation summary reports, and release-readiness documentation. Confirm that testing is appropriately planned, executed, documented, and traceable without assuming responsibility for business-owned testing or project execution.</