Director, Quality Management Systems

BioSpace; Waltham (MA); On-site; USD 196,000 - 230,000; Full time

Job summary

Dyne Therapeutics is seeking a Director of Quality Management Systems based in Waltham, MA. The role leads global QMS design, supplier quality, audits, and product complaint management, ensuring an inspection-ready, scalable system aligned with ICH Q10, FDA CFRs, and international standards.

The position partners with cross-functional teams to embed quality as a strategic driver, balancing risk, compliance, and business needs while scaling toward commercial operations.

Qualifications

• 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

Responsibilities

• Leads QMS strategy, compliance & inspection readiness for commercial operations
• Manages risk-based internal audits and CAPA processes across functions
• Oversees supplier quality program and supplier qualification
• Manages end-to-end product complaint management lifecycle for commercial distribution
• Defines quality metrics and KPIs; drives continuous improvement
• Leads eQMS implementation, validation, and governance

Skills

Quality leadership

Regulatory knowledge

Cross-functional leadership

GxP experience

Strategic thinking

Operational execution

Risk management

Communication

Education

Bachelor’s degree in science or Quality Systems Management

Tools

Veeva eQMS

MasterControl

Learning Management Systems

Job description

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.

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 is responsible for key elements of the QMS including supplier quality, audits, and product complaint management programs, ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations. The Director 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

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.