Senior Manager, 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 Senior Manager, GMP QA Operations oversees quality activities associated with contract manufacturing organizations (CMOs) and ensures compliance with FDA and global GMP regulations. Leads tactical GMP QA operations supporting manufacturing, testing, deviation investigations, and CAPA implementation to enable compliant product disposition for clinical development and future commercialization. Partners cross-functionally to ensure quality systems are effectively applied and continuously improved to support Dyne Therapeutics’ pipeline.

This is an onsite role based in Waltham, MA.

Primary Responsibilities Include:

Quality Operations Execution

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

• Assembles product disposition packages and Certificates of Conformance to support clinical trial supply and commercialization readiness

• Ensures timely and compliant execution of GMP QA activities across manufacturing and testing operations

External Manufacturing Oversight (CMOs)

• Represents GMP QA in interactions with CMOs, including governance meetings and operational discussions

• Ensures contract manufacturing activities align with applicable regulatory requirements, industry standards, and internal expectations

• Monitors vendor quality performance through defined metrics and ensures adherence to GMP requirements

Quality Systems & Compliance

• Leads and supports GMP investigations, including root cause analysis, CAPA development, tracking, and effectiveness verification

• Partners with internal teams to support change management activities impacting manufacturing and testing

• Works within and enhances internal processes for…