Associate 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 https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.  Role Summary: The Associate Director, Clinical Quality Assurance plays a key role in ensuring that Dyne meets the highest standards of quality and compliance in our clinical efforts.

This role is responsible for building and running a robust quality operations function across clinical sites and vendors, with a core focus on audit management, inspection readiness, and quality study support. This role drives quality assurance activities and work closely with cross-functional teams to enhance the quality of our clinical trials and ensure regulatory compliance.

This role is responsible for the end-to-end lifecycle of clinical site audits, vendor audits, and regulatory inspections, while also leading SOP development and cross-functional quality projects.  This is a hands-on role for someone who can contribute to strategy and operate at the tactical level, setting standards, driving execution, and ensuring the organization is always inspection ready.  This role is based in Waltham, MA without the possibility of being a remote role.   Primary Responsibilities Include  Plan, execute, and oversee clinical site audits and vendor audits (routine, for-cause, and follow-up)  Develop, implement, and continuously refine QA strategies, policies, and procedures to support clinical trial integrity   Serve as the primary point of contact for audit activities, including audit preparation, conduct, reporting, and CAPA management  Ensure timely identification, documentation, and resolution of audit findings  Track audit trends and proactively drive continuous quality improvement  Support inspection readiness activities across the organization, including mock inspections, readiness assessments, and training  Act as a key quality representative during regulatory inspections, supporting responses, document requests, and inspection follow-up  Maintain a state of ongoing inspection readiness rather than reactive preparation  Author, review, and maintain SOPs, work instructions, and quality documentation aligned with GxP and applicable regulatory requirements  Ensure SOPs are practical, scalable, and embedded into day-to-day operations  Partner with cross-functional teams to ensure consistent interpretation and adoption of quality processes  Lead and manage quality-related projects across clinical operations, vendors, and internal teams  Collaborate closely with cross functional teams, and external partners  Provide clear reporting, dashboards, and status updates to leadership on audit outcomes, risks, and remediation progress  Collaborate with cross-functional teams to develop and implement corrective action plans to address audit findings and enhance quality   Work in partnership with clinical operations, regulatory affairs, and data management teams to ensure alignment and consistency in quality standards and regulatory compliance   Stay abreast of industry trends and regulatory updates to enhance Dyne’s QA framework and practices  Lead initiatives aimed at improving clinical trial quality, efficiency, and operational excellence   Education and Skills Requirements  Bachelor’s degree in scientific, allied health, or medical field required  8+ 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)  In-depth knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements  Demonstrated experience managing clinical site audits, vendor audits, and managing quality assurance programs   Experience supporting regulatory inspections (FDA, EMA, or equivalent).  Skilled at effectively communicating quality events and outcomes to internal stakeholders  Excellent interpersonal, verbal, and written communication skills  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 10% based on business needs  MA Pay Range$155,000—$190,000 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.

Dyne Therapeutics is a biotechnology company dedicated to advancing life-changing therapies for patients with serious muscle diseases. Leveraging its expertise in muscle biology, nucleic acid delivery, and gene therapy, Dyne is at the forefront of developing innovative treatments to address unmet medical needs and improve the lives of individuals affected by muscle disorders.