Senior Director, Quality Control

dynetherapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Dyne Therapeutics seeks a Senior Director, Quality Control to lead global GMP-compliant QC strategy and execution across clinical and commercial manufacturing. You will oversee external testing labs, release and stability testing, and CMC sections in regulatory filings, ensuring inspection readiness and data integrity.

You will drive analytical method transfers, validations, and CAPA programs, mentor a high-performing team, and partner with internal stakeholders to support lifecycle management

Responsibilities

• 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.

Job description

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 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 https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

Role Summary:

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.

Primary Responsibilities Include:

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 quality, compliance, and operational objectives.
• Apply sound judgment, situational awareness, collaboration, and negotiation skills to influence outcomes across a highly matrixed environment.
• Collaborate with internal stakeholders to anticipate analytical and Quality Control requirements for clinical development, commercialization, and lifecycle management.

People and Organizational Leadership

• Build and strengthen technical Quality Control capabilities to support corporate goals, pipeline advancement, and future growth.
• Recruit, coach, and mentor team members while supporting professional development and career growth.
• Establish clear priorities, promote accountability, and ensure resources are aligned with functional and organizational objectives.
• Foster an inclusive, collaborative, and high-performing team culture focused on quality, continuous improvement, and results.
• Empower team members and leaders to exercise sound judgment, take ownership of outcomes, and work effectively across functions.
• Promote transparent communication, constructive feedback, and effective collaboration with internal and external partners.

Education and Skills Requirements:

• Bachelor's degree in biology, a