Director, Quality Management Systems

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 and follow us onXLinkedInandFacebook.

Role Summary:

The Director QualityManagementSystems is aqualityleader responsible fordesigning scaling and advancing aglobalQuality Management System (QMS)that supports Dynes transition to commercial operations.This roleis responsible forkey elements of the QMS includingsupplierqualityauditsandproductcomplaintmanagementprograms ensuring these systems are inspection-ready risk-based and aligned with global regulatory expectations.TheDirector will partner cross-functionallytoembed quality as a strategic enabler of business performance ensuring systemsare fit-for-purpose inspection-ready scalable and efficientas the organization grows.This is a hands-on leadership role that requires both strategicvision and operationalexecution.

This role is based in Waltham MA.

Primary ResponsibilitiesInclude:

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
• Identifiessystemic quality risks and ensurestimelyCAPA 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 ofeQMSplatforms 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:

• Bachelors degree in a scientific discipline or Quality Systems Management; advanced degree preferred
• 10 years of experience in biotechnology or pharmaceutical environments with exposure acrossGxPs(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 managingeQMSplatforms (e.g. VeevaeQMSMasterControl) 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

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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.