Associate Director, Clinical Quality Assurance

Role Summary

Associate Director, Clinical Quality Assurance plays a key role in ensuring Dyne meets high standards of quality and regulatory compliance in clinical programs. The role builds and runs a robust quality operations function across clinical sites and vendors, focusing on audit management, inspection readiness, and quality study support. It drives quality assurance activities, oversees end-to-end clinical site and vendor audits, regulatory inspections, and leads SOP development and cross-functional quality projects. It is a hands-on role that balances strategy with execution to keep the organization inspection-ready. The position is based in Waltham, MA and is not remote.

Responsibilities

• 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

Qualifications

• 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

Education

• Bachelor’s degree in scientific, allied health, or medical field required

Additional Requirements

• Willingness to travel up to 10% based on business needs