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 Director, Quality  Management   Systems is a  quality   leader 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  s upplier  q uality,  a udit s,   and  p roduct  c omplaint  management   p rograms , ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations .   The  D irector will partner 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 leadership 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  

Core QMS Program Ownership  

Leads a risk-based internal audit program, including planning, execution, and follow-up across functions  

Identifies systemic quality risks and ensures timely CAPA development, closure, and effectiveness checks  

Builds and matures a risk-based supplier quality program, including supplier qualification, monitoring, and ongoing oversight  

Oversees the end-to-end product complaint management lifecycle, including intake, triage, investigation, escalation, and trending, ensuring scalability for commercial distribution  

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  

10+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)  

Demonstrated leadership 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

$196,000 — $230,000 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.