Director/Associate Director, Quality Management Systems

Role: Lead global Quality Management System (QMS) functions, ensuring compliance, inspection readiness, and continuous improvement within a biopharma manufacturing setting. Responsibilities: oversee document control, training, CAPA, deviations, change control, and risk management; manage end-to-end lifecycle of quality documentation; lead implementation and validation of eQMS; support regulatory inspections and audits; embed quality in business processes and drive system performance metrics. Requirements: BSc/MSc/PhD in Life Sciences, 10+ years in GxP biotech/pharma, expertise with GxP regulations (FDA, EMA, MHRA), eQMS validation/maintenance, and audit experience. Preferred: proficiency in Veeva and MS Office tools; demonstrated leadership in inspection management; ability to influence cross-functional teams; about 5-12% travel. High-Value: focus on inspection readiness, regulatory compliance, system validation, and continuous quality improvement aligned with global standards. Work Setup: remote with monthly travel to Norwood, MA.