Associate Director, Quality Management Systems

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

Job summary

Dyne Therapeutics seeks an Associate Director of Quality Management Systems to design, scale, and advance a global QMS aligned with ICH Q10 and global regulatory expectations. The role is hands-on and strategic, partnering across functions to embed quality as a business enabler in preparation for commercial operations.

The successful candidate will lead document control, records management, and training programs, ensuring inspection readiness while scaling to support growth in a fast-paced

Qualifications

• Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred.
• 8+ years of biotech/pharma experience 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.

Responsibilities

• Lead the evolution of the QMS to a commercial-ready, globally scalable system.
• Ensure QMS processes are phase-appropriate, risk-based, and scalable with growth.
• Maintain proactive compliance and inspection readiness.
• Represent QMS during regulatory inspections and health authority interactions.
• Provide strategic and operational leadership for GxP documentation and training programs (eDMS/LMS).
• Oversee end-to-end lifecycle management of quality documents (policies, SOPs, records).
• Drive high-volume document authoring, revision, and implementation under accelerated timelines.
• Lead training curriculum planning and deployment across functions.
• Develop engaging learning materials and assessments for quality programs.
• Lead scale efforts for eDMS/LMS capabilities with validated systems.
• Define and report quality metrics and KPIs; drive continuous improvement and risk reduction.
• Govern eQMS platforms to ensure adoption and lifecycle management.
• Partner with cross-functional stakeholders to embed quality into processes.

Skills

GxP knowledge

QMS ownership

Regulatory understanding

eQMS platforms

LMS implementation

Strategic execution

Multi-project management

Risk management

Written and verbal communication

Autonomy

Education

Bachelor’s degree in scientific discipline or Quality Systems Management

Advanced degree preferred

Tools

Veeva eQMS

MasterControl

Job description

Associate 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) 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 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 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
• 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 and 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

Compensation

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.