Director, Clinical Quality Assurance

Company OverviewDyne 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 https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.Role SummaryThe 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 ResponsibilitiesInform and contribute to audit planning and strategyPerform and/or coordinate clinical site and vendor auditsOversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIsAdvise internal stakeholders and external partners on GCP compliance matters and identify emerging non‑compliance trendsSupport inspection readiness activities and co‑host regulatory inspectionsDevelop and deliver GCP‑related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirementsConduct and/or manage qualification and oversight of service providersEnsure service providers adhere to quality programs and applicable regulations, maintaining inspection readinessAssess and escape compliance risks identified through audits to protect subject safety, data integrity, and business continuityLead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findingsSupport investigational new drug (IND) applications and related correspondence with global regulatory authoritiesEducation and Skills RequirementsBachelor's degree in a scientific, allied health, or medical field required; Master’s degree preferredMinimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience)Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirementsBroad clinical development experience across all phases (Phase I through BLA/NDA)Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stagesProven experience developing and implementing risk‑based clinical quality assurance programsDemonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findingsSkilled at effectively communicating quality events and outcomes to internal stakeholdersExcellent interpersonal, verbal, and written communication skillsWorking knowledge of multiple therapeutic areas is a plusResults‑oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelinesFlexible and creative problem solver with a proactive mindsetHighly collaborative team player who fosters open communication and cross‑functional cooperationWillingness to travel up to 20% based on business needsPay Range$190,000—$232,800 USDEqual Opportunity EmploymentDyne 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. #J-18808-Ljbffr