Quality & Compliance Manager, Computer System Validation

Role overview Provide independent, risk-based quality oversight for computerized systems used in regulated clinical research and laboratory operations. The manager guides validation and assurance across each system’s lifecycle, helping ensure systems are fit for intended use, records remain reliable, and documentation is ready for audits and inspections.

Responsibilities - Review and approve risk assessments, validation plans, requirements, traceability records, test evidence, deviations, summary reports, and release documentation. - Assess whether systems and their controls support data integrity, electronic records and signatures, audit trails, access management, backups, archiving, and retention. - Oversee system changes, incidents, corrective actions, upgrades, data migrations, periodic reviews, and retirement activities; escalate risks and track remediation. - Coordinate with Quality, IT, security, clinical and laboratory teams, system owners, and service providers to establish appropriate controls and clear responsibilities. - Maintain and improve procedures, templates, tools, and training for risk-based validation and software assurance. - Support audits and inspections, keep records complete and retrievable, and track performance and compliance trends to guide improvements.

Requirements - Bachelor’s degree in a relevant life sciences, technical, healthcare, or engineering discipline, or a comparable field. - At least six years of progressively responsible experience in quality assurance, computer system validation or assurance, IT quality, or a related area in regulated life sciences. - Demonstrated independent QA oversight of GxP systems throughout their lifecycle, from risk assessment and validation through change control, periodic review, migration, and retirement. - Experience reviewing and approving validation documentation and evaluating testing, traceability, and release readiness. - Ability to assess data integrity and compliance risks and work effectively across quality, technology, operations, and vendor teams.

Benefits and work setup The role is eligible for a discretionary annual bonus and benefits that include health coverage, retirement savings, life and disability insurance, parental leave, and paid sick and vacation time. The listed salary estimate is $91,500–$120,000 USD; actual compensation may depend on experience, skills, training, and work location. Candidates must be authorized to work in the country of employment without sponsorship.