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Quality & Compliance Manager, Computer System Validation
Job details
About this role
Role overview
Lead quality oversight for computerized systems used in regulated clinical research and laboratory operations. The role sets consistent, risk-based validation practices and works with quality, IT, system owners, operations teams, and service providers to keep systems suitable for their intended use, protect data integrity, and maintain inspection readiness throughout each system’s lifecycle.
Responsibilities
- Provide independent quality oversight from initial system assessment and implementation through operation, periodic review, significant changes, and retirement. - Review and approve risk assessments, validation plans, requirements, traceability records, test evidence, deviation records, summary reports, and release documentation. - Assess controls for electronic records and signatures, audit trails, access, security, backup, archival, and record retention. - Evaluate changes, incidents, corrective actions, upgrades, data migrations, and decommissioning; escalate compliance or data-integrity concerns and track remediation. - Coordinate with internal teams and external providers on system controls, responsibilities, and supplier oversight. - Maintain procedures, templates, tools, training, compliance metrics, and audit or inspection responses; use trends to identify improvements.
Requirements
- Bachelor’s degree in a relevant scientific, technical, healthcare, or information systems discipline. - At least six years of progressively responsible experience in quality assurance, computer system validation, software assurance, IT quality, or a related field in regulated life sciences. - Demonstrated experience providing independent QA oversight across the computerized-system lifecycle, including risk assessment, validation, testing, release, change control, periodic review, incident management, data migration, and retirement. - Experience reviewing and approving validation or assurance records and assessing system fitness for intended use and data integrity. - Ability to work across quality, IT, security, clinical and laboratory operations, system owners, and suppliers.