Dyne Therapeutics
Associate Director, Quality Management Systems
Waltham, MA · Director
Sponsorship not specifiedDetected 15 days ago
GCPGMPFDA RegulatoryAnimal StudiesLeadershipGxP
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
- 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
- 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
- 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
Requirements
- Demonstrated experience with direct ownership of QMS and quality systems
- Proven experience implementing
Nice to have
- Bachelor's degree in a scientific discipline or Quality Systems Management
- advanced degree preferred
- 8+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)
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.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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