Associate Director, Quality Management Systems

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook . Role Summary: The Associate Director, Quality Management Systems is a key member of the quality team responsible for designing, scaling, and advancing a global Quality Management System (QMS) that supports Dyne’s transition to commercial operations. This role i s responsible for key elements of the QMS including document control, records management and training ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations . The Associate D irector partner s cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit -for-purpose, inspection-ready, scalable , and efficient as the organization grows. This is a hands-on role that requires both strategic vision and operational execution . This role is based in Waltham, MA . Primary Responsibilities Include : QMS Strategy, Compliance & Inspection Readiness Leads the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards Ensures QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth Establishes and sustains a proactive compliance model that supports continuous inspection readiness Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions Provides strategic and operational leadership for GxP documentation and training programs, ensuring effective use and governance of the eDMS and LMS in support of the quality management system Core QMS Program Ownership Oversees the end-to-end lifecycle management of quality documents, including policies, SOPs, and related controlled records, ensuring consistency, accuracy, and compliance with applicable regulations that achieves inspection readiness Drives and manage high-volume document authoring, revision, and implementation – often under accelerated timelines Leads the planning, deployment, and governance of role-based training curriculum across functions Leads the design and implementation of learning programs (refresher training, cross-training, etc.) Manages the day-to-day deliver