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.
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.
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
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.
