Senior Director, Clinical Quality Assurance
Dyne TherapeuticsAbout the role
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 functiona
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s