Associate Director, GMP QA Operations

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. 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.

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 Quality Systems & Continuous Improvement Develops, implements, and maintains Quality Systems, procedures, policies, and metrics supporting GMP operations Drives improvements to batch record review processes and ensures timely resolution of compliance issues Manages CMO documentation and ensures accessibility of quality records Develops and monitors Quality Operations metrics (KPIs) for Management Review Audits, Inspection Readiness & Cross-Functional Collaboration Participates in domestic and international audits of CMO sites and supports internal audit programs Collaborates with CMC, Regulatory Affairs, and Project Management to align quality objectives and execution Provides QA Operations training and mentorship to team members Communicates quality risks and issues effectively to stakeholders to support informed decision-making Education and Skills

, Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry) 5+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry, preferably with experience overseeing CMO/CDMO organizations. Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations. A proven track record of demonstrating good judgement & decision-making experience.