Director/Associate Director, Quality Management Systems

Role: Lead global Quality Management Systems (QMS) strategy and operations, ensuring compliance, inspection readiness, and continuous improvement within a biopharma setting. Responsibilities: oversee key QMS elements including Document Control, Records, Training, Deviations, CAPA, Change Control, and Risk Management; manage end-to-end lifecycle of quality documentation; lead and optimize eQMS validation, maintenance, and adoption; support regulatory inspections and audits; embed quality into business processes; and drive operational excellence through process standardization and performance metrics. Requirements: Bachelor’s or higher in Life Sciences; 10+ years in GxP biotech/pharma industries; strong knowledge of GxPs and global regulatory standards (FDA, EMA, MHRA); experience with eQMS systems, validation, and quality compliance; proven project leadership, cross-functional collaboration, and inspection management skills. Preferred: proficiency with Veeva suite, Microsoft Office, and team leadership in fast-paced environments. HighValue: focus on Quality Systems, document control, CAPA, deviation management, risk-based approaches, and regulatory readiness; involvement in inspection preparedness and audit support; based in Boston with 5-12% travel. WorkSetup: hybrid in Norwood, MA, combining strategic oversight and hands-on operational execution.