Dyne Therapeutics
Associate Director, Quality Management Systems
Waltham, MA · Director
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About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- 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.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- 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
- 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
- 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 technical sessions as needed to scale eDMS/LMS capabilities
- Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness
Benefits
- Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions
- 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
- Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.