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 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 , and follow us on X, Linked In 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 is 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 Director partners 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 delivery of programs to ensure consistent quality and alignment to employees and their learning goals

* Drives development and review of engaging learning materials/ assessments to support learning programs utilizing multiple delivery methods

* Leads technical sessions as needed to scale eDMS/LMS capabilities

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 a culture of accountability, transparency, and continuous improvement

Education and Skills Requirements:

* Bachelor's degree in a scientific discipline or Quality Systems Management; advanced degree preferred

* 8+…