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 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.
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 batch record review and quality event management to ensure timely resolution of compliance issues
- Develops and tracks Quality Operations metrics (KPIs) for Management Review
Cross-Functional Collaboration & Continuous Improvement
- Collaborates with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Project Management to ensure alignment on quality objectives
- Partners with Quality Management Systems teams to drive consistency and continuous improvement across quality processes
- Communicates quality risks, issues, and trends clearly 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.
