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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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. 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 Director, Quality  Management   Systems is a  quality   leader 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  s upplier  q uality,  a udit s,   and  p roduct  c omplaint  management   p rograms , ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations .   The  D irector will partner 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 leadership 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   Core QMS Program Ownership   Leads a risk-based internal audit program, including planning, execution, and follow-up across functions   Identifies systemic quality risks and ensures timely CAPA development, closure, and effectiveness checks   Builds and matures a risk-based supplier quality program, including supplier qualification, monitoring, and ongoing oversight   Oversees the end-to-end product complaint management lifecycle, including intake, triage, investigation, escalation, and trending, ensuring scalability for commercial distribution   Operational Excellence & Systems Enablement   Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends   Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness   Leads the implementation, optimization, and governance of eQMS platforms, ensuring validated systems, strong user adoption, and effective lifecycle management   Cross-Functional Leadership & Quality Culture   Partners with cross-functional stakeholders to embed quality into business processes and decision-making   Communicates quality risks, dependencies, and tradeoffs with clarity and urgency, influencing outcomes without direct authority   Contributes to building a high-performing quality organization and models