Senior Manager, Diagnostic (IVD) and Laboratory Operational Quality Lead

Description: • We are seeking a Senior Manager, Diagnostic (IVD) and Laboratory Operational Quality Lead to join our Precision Medicine Team! • The candidate will drive cross-functional excellence across diagnostic operations, quality & compliance execution, and clinical diagnostic delivery. • This individual will develop, implement, and maintain a robust process for the assessment of in vitro diagnostic (IVD) products used within our clinical trials. • This role is responsible for ensuring adherence to global IVD regulations and quality requirements to help manage delivery of diagnostics to support our drug development portfolio. Requirements: • Minimum Bachelor's Degree (Master’s level degree preferred) with 8 years of relevant experience. • Expertise in IVD applications in the clinical trial setting • Diagnostic and laboratory quality, regulatory & compliance experience • Solid understanding of global regulatory requirements (e.g. EU IVDR, 21 CFR 820, ISO 13485, ISO 14971, CAP/CLIA, ICH, GDP, etc.) • Strong understanding of laboratory practices, validation procedures and regulatory requirements. • Proficient in business technology tools and understanding data (e.g. Microsoft Teams, Excel, PowerPoint, etc.) • Drug development experience preferred • Design History File audit expertise, not required but of interest • Must be able to travel up to 25% Benefits: • health and wellness programs • fitness centers • equity awards • annual bonuses • paid time off for eligible employees Apply tot his job Apply To this Job