Director, Operations

Role: Senior leader overseeing Baltimore site operations within a regulated in vitro diagnostic (IVD) manufacturing setting for Labcorp Oncology. Objectives include ensuring operational excellence across manufacturing, supply chain, engineering, facilities, quality, and EHS to deliver high-quality diagnostics products. Responsibilities: direct multi-functional teams, drive continuous improvement and compliance with FDA, ISO 13485, cGMP, and regulatory standards; develop strategic operational plans supporting growth and capacity expansion; lead quality, safety, and performance metrics; support product lifecycle from tech transfer to commercialization; manage budgets, capital planning, and workforce strategies; foster a culture of accountability and leadership development. Requirements: Bachelor's in Engineering, Life Sciences, or related field; 10+ years in regulated manufacturing or operations, with 5+ years leading managers and cross-disciplinary teams; extensive experience supporting regulatory inspections, quality compliance, NPI, and scale-up activities. Preferred: Master’s degree; Lean/Six Sigma certifications; experience with 510(k) and PMA processes; global manufacturing exposure; facilities and EHS management. HighValue: IVD/diagnostics manufacturing, regulated environment (FDA, ISO 13485, cGMP), product lifecycle support, senior leadership, operational excellence, cross-functional collaboration. WorkSetup: Baltimore, MD, Monday–Friday, 1st shift.