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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. 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 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 i s 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 D irector partner s 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+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)  

Demonstrated experience with direct ownership of QMS and quality systems  

Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements  

Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems  

Strong strategic and operational capability, balancing vision-setting with hands-on execution  

Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment  

Strong judgment and risk management skills, balancing compliance, science, and business needs  

Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders  

Highly proactive, accountable, and comfortable operating with a high degree of autonomy  

#LI-Onsite

MA Pay Range

$160,000 — $195,000 USD

 

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.