Senior Director, Quality Control

Our commitment to people with neuromuscular diseases

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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations.

At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at , and follow us onX ,Linked In and Facebook .

The Senior Director, Quality Control leads the strategy and execution of Quality Control activities that support clinical and commercial manufacturing, pipeline advancement, and product lifecycle management. This role ensures global GMP compliance, inspection readiness, and robust analytical support across external testing laboratories, including release and stability testing.

The Senior Director partners closely with contract manufacturing and testing organizations and collaborates across Analytical and Process Development, Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs, and Project Management to advance quality and business objectives.

This position is based in Waltham, MA and is not eligible for remote work.

QC Strategy, Compliance, and Regulatory Readiness

• Define and execute the Quality Control strategy in alignment with quality and business objectives.
• Ensure contract testing laboratories meet global GMP requirements and maintain inspection readiness.
• Represent Quality Control during regulatory inspections.
• Author, review, and approve analytical Chemistry, Manufacturing, and Controls sections of Investigational New Drug applications, Biologics License Applications, and Marketing Authorization Applications.
• Evaluate and implement effective tools for analytical data review, statistical analysis, stability assessment, and expiry assignment.
• Lead internal Specification and Stability Review Boards and facilitate clear, timely, and risk-based decisions.

Technical and Operational Leadership

• Lead the authoring, review, and approval of analytical method transfers, qualifications, and validations.
• Oversee external testing laboratory operations, release and stability testing, and the issuance of Certificates of Analysis.
• Review environmental monitoring, sterility, bioburden, and endotoxin data and participate in related reviews and investigations.
• Lead the establishment and revision of drug substance and drug product specifications, including the development of appropriate scientific and regulatory rationale.
• Lead Quality Control compliance activities, including change controls, corrective and preventive actions, and data integrity initiatives.
• Lead out-of-specification and out-of-trend investigations and ensure appropriate root-cause analysis, corrective actions, and timely resolution.
• Oversee the reference standard program across external testing vendors.

Performance, Analytics, and Vendor Partnership

• Build Quality Control capabilities in stability data analysis, biological assays, and statistical analysis to support evolving portfolio and business needs.
• Analyze laboratory performance and quality metrics and present findings, risks, trends, and recommendations in internal and vendor governance forums.
• Partner with contract manufacturing and testing organizations to align expectations, resolve complex issues, and drive reliable execution.
• Establish clear performance expectations for external laboratories and monitor execution against…