Associate Director, Clinical Quality Assurance

Role Summary:

The Associate Director, Clinical Quality Assurance plays a key role in ensuring that Dyne meets the highest standards of quality and compliance in our clinical efforts. This role is responsible for building and running a robust quality operations function across clinical sites and vendors, with a core focus on audit management, inspection readiness, and quality study support. This role drives quality assurance activities and work closely with cross-functional teams to enhance the quality of our clinical trials and ensure regulatory compliance. This role is responsible for the end-to-end lifecycle of clinical site audits, vendor audits, and regulatory inspections, while also leading SOP development and cross-functional quality projects. 

This is a hands-on role for someone who can contribute to strategy and operate at the tactical level, setting standards, driving execution, and ensuring the organization is always inspection ready. 

This role is based in Waltham, MA without the possibility of being a remote role.  

Primary Responsibilities Include 

• 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  

Education and Skills Requirements 

• Bachelor’s degree in scientific, allied health, or medical field required 
• 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 
• Willingness to travel up to 10% based on business needs