Associate Director, Quality Management Systems

Role: Associate Director, Quality Management Systems at Dyne Therapeutics, leading the development and scalability of global QMS to support transition to commercial manufacturing, with a focus on compliance, inspection readiness, and risk management. Responsibilities: oversee document control, records management, and training programs; drive QMS strategy aligned with international standards (ICH Q10, FDA CFRs); serve as subject matter expert during regulatory inspections; manage lifecycle of quality documents and training curricula; define and monitor QMS metrics; lead continuous improvement and systems optimization; partner cross-functionally to embed quality into business processes, fostering a culture of accountability and transparency. Requirements: Bachelor's in a scientific or quality discipline; 8+ years in biotech/pharma, with direct QMS ownership experience; in-depth knowledge of GxP regulations, global requirements (FDA, ICH, EU); proven experience with eQMS platforms (e.g., Veeva, MasterControl) and LMS; strong strategic, operational, and communication skills; ability to manage multiple initiatives in a fast-paced environment. HighValue: focus on GxP systems, inspection readiness, global regulatory compliance, scalable quality frameworks, and systems enablement. Location: Waltham, MA.