Quality Assurance Manager

Job Summary

Managing the quality oversight and lifecycle validation of GxP computerized systems, the remote Quality Assurance Manager will ensure systems are compliant, maintain data integrity, and support continuous improvement across clinical and laboratory environments.

Key responsibilities

• Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout their lifecycle
• Review and approve validation and assurance deliverables, ensuring appropriate testing and documentation
• Prepare for and support audits and inspections, ensuring validation records are complete and inspection-ready

Required qualifications

• Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or a related field
• Minimum of six years of experience in Quality Assurance or computer system validation within a regulated life sciences environment
• Demonstrated experience providing QA oversight of GxP computerized systems throughout their lifecycle
• Working knowledge of regulatory requirements, including FDA electronic-record and electronic-signature requirements
• Experience supporting computerized systems used in CRO, clinical research, or laboratory operations