Director, Operations
Core
Senior leadership role leading Baltimore site operations for a highly regulated in vitro diagnostic (IVD) development and manufacturing environment.
Role type
Director of Operations (Senior Leadership)
Builds
High-quality IVD products and services for internal and external customers
Domain
Life Sciences / In Vitro Diagnostics (IVD) Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Manufacturing Operations)
Required skills
Strategic operational leadership, cross-functional team management, regulatory compliance (FDA, ISO 13485, cGMP), Lean Manufacturing, Six Sigma, budget management, capital planning, workforce strategy, new product introduction (NPI), technology transfer, process validation
Preferred skills
Master's degree in Operations/Supply Chain/Life Sciences, 510(k)/PMA/IVD product development experience, global manufacturing environment experience, facilities and EHS program management
Technologies
FDA regulations, ISO 13485, cGMP, Quality Management Systems
Responsibilities
Provide leadership to multi-functional operations org (manufacturing, supply chain, engineering, facilities, EHS); Establish high-performance culture focused on accountability and continuous improvement; Lead manufacturing operations ensuring regulatory compliance; Drive operational performance via KPIs (safety, quality, cost, productivity); Develop strategic operational plans for scale-up and capacity planning; Champion Lean/Six Sigma initiatives; Build leadership capability through coaching and succession planning; Lead readiness for regulatory inspections and audits; Partner on technology transfer and NPI; Own site-level budget, capital planning, and workforce strategy
Seniority
Director, Senior Leadership