Role Summary:

The Director, Quality Management Systems is a quality leader responsible for designing, scaling, and advancing a global Quality Management System (QMS) that supports Dyne’s transition to commercial operations. This role is responsible for key elements of the QMS including supplier quality, audits, and product complaint management programs, ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations. The Director will partner cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit-for-purpose, inspection-ready, scalable, and efficient as the organization grows. This is a hands-on leadership role that requires both strategic vision and operational execution. 

This role is based in Waltham, MA. 
 
Primary Responsibilities Include: 

QMS Strategy, Compliance & Inspection Readiness 

• Leads the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards 
• Ensures QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth 
• Establishes and sustains a proactive compliance model that supports continuous inspection readiness 
• Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions 

Core QMS Program Ownership 

• Leads a risk-based internal audit program, including planning, execution, and follow-up across functions 
• Identifies systemic quality risks and ensures timely CAPA development, closure, and effectiveness checks 
• Builds and matures a risk-based supplier quality program, including supplier qualification, monitoring, and ongoing oversight 
• Oversees the end-to-end product complaint management lifecycle, including intake, triage, investigation, escalation, and trending, ensuring scalability for commercial distribution 

Operational Excellence & Systems Enablement 

• Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends 
• Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness 
• Leads the implementation, optimization, and governance of eQMS platforms, ensuring validated systems, strong user adoption, and effective lifecycle management 

Cross-Functional Leadership & Quality Culture 

• Partners with cross-functional stakeholders to embed quality into business processes and decision-making 
• Communicates quality risks, dependencies, and tradeoffs with clarity and urgency, influencing outcomes without direct authority 
• Contributes to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement 

 Education and Skills Requirements: 

• Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred 
• 10+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred) 
• Demonstrated leadership experience with direct ownership of QMS and quality systems 
• Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements 
• Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems 
• Strong strategic and operational capability, balancing vision-setting with hands-on execution 
• Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment 
• Strong judgment and risk management skills, balancing compliance, science, and business needs 
• Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders 
• Highly proactive, accountable, and comfortable operating with a high degree of autonomy 

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