Associate Director, GMP QA Operations

About this role

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 Associate Director, QA Operations serves as the QA technical lead for external manufacturing and testing project teams, ensuring the effective development, implementation, and continuous improvement of Quality Systems, procedures, policies, and metrics supporting GMP activities. Provides leadership across QA operations while proactively identifying and mitigating compliance risks and serving as a subject matter expert for complex quality issues and escalations. Contributes to functional strategy and partners cross-functionally to ensure quality excellence across development and manufacturing activities.

This position is based in Waltham, MA.

Primary Responsibilities Include:

External Manufacturing Oversight & Quality Leadership

• Serves as QA lead for external manufacturing and testing teams, providing technical guidance and quality oversight

• Represents QA Operations in interactions with CMOs and external partners

• Ensures contract manufacturing activities align with current regulatory requirements, standards, and industry best practices

• Participates in CMO Quality Agreement review and management

Quality Operations Execution & Compliance

• Oversees release activities for Drug Substance Intermediates (DSI), Drug Substance (DS), and Drug Product (DP), including batch record review and disposition decisions

• Leads or supports investigations into significant quality issues, driving root cause analysis and CAPA development, tracking, and effectiveness verification

• Supports change management activities impacting manufacturing and testing

• Provides input into specifications, stability protocols, and product labeling as needed

• Supports regulatory submissions, including investigational new drug applications and related correspondence