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 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 https://x.com/dyne_tx, https://www.linkedin.com/company/dynetx/ and https://www.facebook.com/DyneTherapeutic/. 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. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.  This role is based in Waltham, MA.   Primary Responsibilities Include: 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 the qualification and oversight of service providers  Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness  Assess and escalate 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: Bachelor’s degree in a scientific, allied health, or medical field required; Master’s degree preferred  Minimum 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 requirements  Broad clinical development experience across all phases (Phase I through BLA/NDA)  Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages  Proven experience developing and implementing risk-based clinical quality assurance programs  Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings  Skilled at effectively communicating quality events and outcomes to internal stakeholders  Excellent interpersonal, verbal, and written communication skills  Working knowledge of multiple therapeutic areas is a plus  Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines  Flexible and creative problem solver with a proactive mindset  Highly collaborative team player who fosters open communication and cross-functional cooperation  Willingness to travel up to 20% based on business needs    #LI-Onsite MA Pay Range$190,000—$232,800 USD   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. Offices: Waltham, Massachusetts, United States (Waltham, MA);