Manager, QA Method Validation
Core
Leading laboratory method validation for assays and devices in clinical and GMP settings to ensure compliance and data quality for breakthrough therapies.
Role type
Manager, QA Method Validation
Builds
Validated analytical methods and devices for clinical and GMP laboratory use
Domain
Life Sciences / Clinical Diagnostics / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method validation protocols, GxP compliance, Risk assessment, Audit preparation, Technology transfer oversight, Statistical analysis, Molecular biology basics, Immunology, Flow cytometry, Regulatory guidelines (IVDR, CLIA/CAP)
Preferred skills
Ligand binding assays, Digital pathology, Continuous improvement
Technologies
GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR
Responsibilities
Lead review and approval of method validation protocols and reports, Provide quality guidance on validations and troubleshooting, Serve as Quality representative on design teams, Evaluate risk assessments and deviations, Lead audits and inspections, Assist with quality management of technology transfer
Seniority
Manager, hands-on IC