Manager, QA Method Validation

Role: Lead laboratory method validation in a regulated clinical and GMP environment, ensuring assay accuracy, compliance, and quality oversight. Responsibilities: review and approve validation protocols and reports, provide guidance on validations, troubleshoot, assess risks and deviations, support audits and inspections, and oversee technology transfer documentation and training compliance. Requirements: Bachelor's degree in engineering, medical technology, or biological sciences with a minimum of 8 years' experience in clinical or GMP labs; at least 3 years supporting in vitro diagnostic development; familiarity with regulatory standards such as GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR; basic knowledge of molecular biology, immunology, flow cytometry, and statistics. Preferred: experience with ligand binding assays, digital pathology, and continuous improvement initiatives. High-Value: clinical assay validation, in vitro diagnostics, regulatory compliance, GMP and GxP expertise, cross-functional collaboration with design teams. Work setup: based in Carlsbad, California; relocation support not provided; no specific travel requirements noted.