Director, Clinical Quality Assurance

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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and 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 and follow us on X, and Facebook.

Role Summary

The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. The Director partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. This role establishes program support to uphold industry best practices and regulatory requirements.

Location : Waltham, MA (no remote role).

Primary Responsibilities

• Inform and contribute to audit planning and strategy
• Perform and / or coordinate clinical site and vendor audits
• Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
• Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non‑compliance trends
• Support inspection readiness activities and co‑host regulatory inspections
• Develop and deliver GCP‑related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements
• Conduct and / or manage qualification and oversight of service providers
• Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
• Assess and escape compliance risks identified through audits to protect subject safety, data integrity, and business continuity
• Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
• Support investigational new drug (IND) applications and related correspondence with global regulatory authorities

Education and Skills Requirements

Pay Range

$190,000—$232,800 USD

Equal Opportunity Employment

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.

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