Director/Associate Director, Quality Management Systems

Role: Lead global Quality Management Systems (QMS) for a biotech organization, focusing on document control, training, deviations, CAPA, change control, and risk management to ensure inspection readiness and compliance with regulatory standards. Responsibilities include overseeing end-to-end lifecycle management of quality documents, deploying quality training programs, supporting regulatory inspections, and driving continuous improvement initiatives. Serve as QMS owner for the eQMS system, ensuring validation, performance, and enterprise adoption; lead validation, system governance, and process enhancements. Requirements: Bachelor's in Life Sciences; 10+ years in GxP biotech/pharma, with expertise in GxPs, FDA, EMA, and MHRA regulations; strong experience with eQMS systems, validation, and audit readiness. Preferred skills include excellent communication, project management, cross-functional collaboration, and proficiency in Veeva and MS Office. High-value details: Focus on quality systems within a biotech environment, supporting commercialization readiness, with some travel (~5-12%) for meetings and audits. Location: Norwood, MA, with three days onsite.