Dyne Therapeutics
Director, Quality Management Systems
Waltham, MA · Director
Sponsorship not specifiedDetected 21 days ago
AuditingFDA RegulatoryAnimal StudiesLeadershipInternal Audit
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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
- 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
- Leads a risk-based internal audit program, including planning, execution, and follow-up across functions
- Builds and matures a risk-based supplier quality program, including supplier qualification, monitoring, and ongoing oversight
- 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
- Partners with cross-functional stakeholders to embed quality into business processes and decision-making
- Contributes to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement
Benefits
- Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions
- 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.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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