Senior Director, Clinical Quality Assurance

4w4 weeks ago

Dyne Therapeutics

Waltham, US · Full-time · $225,000 – $285,000

About this role

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Senior Director, Clinical Quality Assurance partners with 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 and ensures sustained inspection readiness. The Senior Director proactively identifies and mitigates quality risks, overseeing deviations, quality issues, CAPAs, and effectiveness checks, driving robust root cause analyses and meaningful performance metrics.

The Senior Director partners closely with senior cross-functional leaders to influence clinical development strategy and strengthen sponsor oversight. They lead the development and continuous improvement of quality systems, policies, SOPs, and governance models to embed a culture of quality and continuous improvement across the organization.

The Senior Director serves as a subject matter expert, shaping policies, standards, and external partnerships to ensure adherence to global regulatory requirements. They also lead organizational inspection readiness and serve as executive sponsor for regulatory inspections, offering the opportunity to impact clinical programs for Duchenne muscular dystrophy and myotonic dystrophy.

Requirements

In-depth knowledge of Good Clinical Practices (GCP) and global regulatory requirements (FDA, EMA, ICH).
Proven experience in leading clinical audit programs and vendor oversight within the pharmaceutical or biotech industry.
Strong strategic thinking and ability to develop and implement risk-based quality frameworks.
Demonstrated experience in managing regulatory inspections and responding to inspection findings and CAPAs.
Leadership experience in cross-functional team environments, with ability to influence senior stakeholders.
Excellent analytical and problem-solving skills, with focus on root cause analysis and meaningful performance metrics.
Familiarity with neuromuscular disease therapeutic areas and related clinical development challenges.

Responsibilities

Define and execute the Clinical Quality Assurance strategy aligned with organizational priorities.
Provide strategic oversight of clinical site and vendor audit programs, ensuring effectiveness, consistency, and scalability.
Oversee deviations, quality issues, CAPAs, and effectiveness checks, driving robust root cause analyses and meaningful performance metrics.
Lead organizational inspection readiness strategy and serve as executive sponsor for regulatory inspections.
Engage with regulatory authorities and external partners on complex quality and compliance matters.
Lead the development and continuous improvement of quality systems, policies, SOPs, and governance models.
Identify systemic quality risks and lead cross-functional mitigation strategies to protect subject safety, data integrity, and business continuity.
Partner with senior leadership to embed a culture of quality and accountability across the organization.