Quality & Compliance Manager, Computer System Validation
Core
Manage quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations to ensure data integrity and regulatory compliance.
Role type
Senior IC Quality & Compliance Manager (Computer System Validation) (via careerplan.io/jobs/6217581004-quality-compliance-manager-computer-system-validation-at-precisionmedicinegroup)
Builds
Validated GxP computerized systems for clinical research and laboratory activities
Domain
Life Sciences / Regulatory Compliance / Computer System Validation
Required skills
GxP system lifecycle management, risk-based validation, regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, ICH GCP/GLP), data integrity principles, vendor qualification, audit preparation, CAPA management, change control, stakeholder collaboration
Preferred skills
Master's degree in relevant field, experience in CRO/biotech/pharma, managing global validation teams, laboratory platform expertise (LIMS, ELN, CDS), clinical platform expertise (EDC, CTMS, eTMF), Agile/Waterfall methodologies, professional certifications (ASQ, ISACA)
Technologies
LIMS, ELN, CDS, EDC, CTMS, eTMF, IRT/RTSM, eCOA/ePRO, cloud platforms, SaaS solutions
Responsibilities
Provide independent QA oversight of GxP systems from implementation to retirement; Review and approve validation deliverables (plans, risk assessments, test evidence, reports); Ensure systems fit for intended use and compliant with regulatory requirements; Oversee changes, incidents, deviations, and data migrations; Support supplier qualification and audits; Develop and maintain validation policies and tools; Prepare for sponsor audits and regulatory inspections; Report metrics on validation status and compliance trends
Seniority
Senior, hands-on IC