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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. 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.