Associate Director, Quality Management Systems

Dyne Therapeutics; Waltham (MA); On-site; USD 160,000 - 195,000; Full time

Job summary

Dyne Therapeutics, based in Waltham, MA, seeks an Associate Director, Quality Management Systems to design and scale a global QMS for commercial operations. You will own document control, records management, and training, ensuring systems are inspection-ready and aligned with global regulations.

The role emphasizes strategic vision with hands‑on execution, cross‑functional leadership, and delivering scalable QMS that supports rapid organizational growth.

Qualifications

• Bachelor’s degree in science or quality systems; advanced degree preferred.
• 8+ years in biotech/pharma with GxP exposure (GCP/GLP/GMP).
• Direct ownership of QMS and quality systems.
• Strong understanding of global regulatory requirements (FDA CFRs, ICH, EU Annex).
• Experience implementing eQMS platforms and LMS.

Responsibilities

• Lead the evolution of a commercial-ready, scalable QMS.
• Ensure QMS processes are risk-based and inspection ready.
• Represent QMS in regulatory inspections and health authority interactions.
• Oversee documentation, policies, SOPs, and controlled records.
• Develop training curricula across functions and scale eDMS/LMS usage.
• Manage learning materials and assessments for quality programs.
• Drive KPIs to monitor system health and compliance risk.
• Partner with stakeholders to embed quality into business processes.

Skills

Quality systems

Regulatory knowledge

eQMS platforms

Leadership

Cross-functional collaboration

Training programs

Quality metrics

Education

Bachelor’s degree in a scientific discipline

Quality Systems Management

Advanced degree preferred

Tools

Veeva eQMS

MasterControl

Learning Management Systems (LMS)

Job description

Associate Director, Quality Management Systems

Waltham, MA

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) 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

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 is 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 Director partners 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

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 manages 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 & 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.

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.