Senior Director, Clinical Quality Assurance

Dyne Therapeutics • Waltham, MA

7h • $225,000 - $285,000

About The Position

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.

Requirements

• Bachelor’s degree in a scientific, allied health, or medical field required
• 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
• Results-oriented with the ability to manage competing priorities and operate effectively in a dynamic environment
• Flexible, proactive, and solutions-oriented mindset

Nice To Haves

• Master’s degree preferred
• Working knowledge of multiple therapeutic areas is preferred

Responsibilities

• 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
• 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
• 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
• 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

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior