Senior 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 X, LinkedIn and Facebook.

Role Summary

The Senior Director, Clinical Quality Assurance (QA) partners with the Quality Assurance leadership to define, lead, and execute the strategic direction for Good Clinical Practices (GCP) compliance and quality oversight across clinical programs and commercial readiness activities. This role establishes and evolves enterprise-wide, risk-based quality strategies; ensures sustained enterprise-wide inspection readiness; and proactively identifies and mitigates quality risks. This role partners closely with senior cross-functional leaders to influence clinical development strategy, strengthen sponsor oversight, and embed a culture of quality and continuous improvement. The Senior Director, Clinical QA serves as a subject matter expert, shaping policies, standards, and external partnerships to ensure adherence to global regulatory requirements and industry best practices.

Primary Responsibilities Include:

Strategy & Functional Leadership

• Partner to define and execute the Clinical Quality Assurance strategy aligned with organizational priorities
• Establish and evolve enterprise-wide risk-based frameworks for GCP compliance, audit strategy, and inspection readiness
• Influence clinical development and operational strategies through a quality and compliance lens
• Lead the development and continuous improvement of quality systems, policies, SOPs, and governance models

Quality Oversight & Risk Management

• Provide strategic oversight of clinical site and vendor audit programs, ensuring effectiveness, consistency, and scalability
• Oversee deviations, quality issues (QIs), CAPAs, and effectiveness checks, driving robust root cause analyses and meaningful performance metrics
• Identify systemic quality risks and lead cross-functional mitigation strategies to protect subject safety, data integrity, and business continuity
• Establish processes to detect, trend, and proactively address compliance risks across programs and vendors

Regulatory Inspection & External Engagement

• Lead organizational inspection readiness strategy and serve as executive sponsor for regulatory inspections
• Oversee preparation, execution, and response to global regulatory inspections and audits, ensuring timely and compliant resolution of findings
• Engage with regulatory authorities and external partners on complex quality and compliance matters
• Strengthen and oversee strategic relationships with service providers to ensure adherence to quality standards and regulatory expectations
• Monitor quality performance metrics, trends, and signals to drive proactive risk mitigation
• Lead preparation for and management of regulatory inspections, including responses to findings and CAPAs

Organizational Influence & Capability Building

• Partner with senior leadership to embed a culture of quality, accountability, and continuous improvement across functions
• Develop and scale GCP training frameworks and capability-building initiatives across the organization
• Provide expert guidance to internal and external stakeholders on evolving regulatory requirements, inspection trends, and industry best practices

Education and Skills Requirements:

• Bachelor’s degree in a scientific, allied health, or medical field required; Master’s degree preferred
• 15+ years of progressive experience in the pharmaceutical or biotechnology industry, including significant leadership experience in Clinical Quality Assurance
• Deep and comprehensive knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GCP, GVP, GxP)
• Broad clinical development experience across all phases (Phase I through BLA/NDA/MAA)
• Proven track record of developing and leading risk-based clinical quality assurance strategies at a functional or organizational level
• Extensive experience overseeing regulatory inspections, health authority interactions, and global audit programs
• Demonstrated ability to influence at all levels of the organization and drive cross-functional alignment on complex quality initiatives
• Strong strategic thinking skills, with the ability to translate regulatory requirements into scalable business processes
• Excellent interpersonal, verbal, and written communication skills, with experience engaging executive-level stakeholders
• Working knowledge of multiple therapeutic areas is preferred
• Results-oriented with the ability to manage competing priorities and operate effectively in a dynamic environment
• Flexible, proactive, and solutions-oriented mindset
• Willingness to travel up to 20% based on business needs

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.