Associate Director, QMS Operations

Role: Associate Director, QMS Operations, overseeing key Quality Management System processes such as Deviations, CAPA, Complaints, and Change Control within a biotech/pharma environment. Responsibilities: establish process standards, drive continuous improvement, ensure compliance with GxP and regulatory requirements, oversee investigations and root cause analysis, monitor KPIs and trends to identify risks, partner cross-functionally with Quality, Manufacturing, Supply Chain, and Regulatory teams, support audits and inspections, and lead process harmonization and electronic QMS enhancements. Requirements: Bachelor's in scientific or engineering discipline; 8-10 years in quality within regulated life sciences, with strong expertise in Deviations, CAPA, investigations, and regulatory standards; proven experience as a process owner or in enterprise quality initiatives; excellent analytical, problem-solving, and communication skills. Preferred: advanced degree, experience supporting regulatory audits, risk management capabilities. HighValue: GxP compliance, Deviations, CAPA, root cause analysis, regulated biopharma (pharma/biotech), process optimization, cross-functional collaboration. WorkSetup: hybrid (2-3 days onsite Waltham, MA); travel up to 10%.