Plant Manager, Site Lead - Burlington

Role: Senior Plant Manager and Site Lead for manufacturing operations supporting pharmaceuticals, medical devices, and combination products at a GMP-compliant facility. Responsibilities: provide strategic and operational leadership across formulation, sterile processing, device assembly, packaging, and related functions; ensure compliance with FDA, ISO, cGMP, and other regulatory standards; lead technology transfers, process validations, and product launches; foster a culture of safety, quality, continuous improvement, and digital transformation; partner with Quality, Engineering, Supply Chain, R&D, and Regulatory teams; develop KPIs, oversee budgets, and support facility expansion and equipment investments; lead talent development and organizational change. Requirements: Bachelor's degree (advanced degree preferred); 15+ years of experience in regulated manufacturing environments; 10+ years in senior manufacturing leadership, including site or plant roles; deep knowledge of FDA regulations, cGMP, 21 CFR Parts 210/211 and 820, ISO 13485; proven success in quality systems, regulatory inspections, and supporting product launches; expertise in Lean, Six Sigma, operational excellence, and sterile manufacturing. HighValue: pharmaceutical/biotech/medical device manufacturing, sterile/aseptic processes, complex product support, regulatory compliance, technology transfer, scale-up from development to commercial, global quality standards. WorkSetup: on-site in Burlington, MA; no travel specified.