Associate Director, Quality Management Systems

Responsibilities

• Lead the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards
• Ensure QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth
• Establish and sustain a proactive compliance model that supports continuous inspection readiness
• Serve as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections
• Provide strategic and operational leadership for GxP documentation and training programs, including eDMS and LMS governance
• Oversee the end-to-end lifecycle management of quality documents, policies, and SOPs
• Lead the planning, deployment, and governance of role-based training curriculum
• Define, monitor, and report quality metrics and KPIs to assess system health and compliance risk
• Drive continuous improvement initiatives to enhance efficiency and strengthen QMS robustness
• Partner with cross-functional stakeholders to embed quality into business processes

Requirements

• Bachelor’s degree in a scientific discipline or Quality Systems Management
• 8+ years of experience in biotechnology or pharmaceutical environments
• Exposure across GxPs (GCP, GLP, GMP, GVP preferred)
• Demonstrated experience with direct ownership of QMS and quality systems
• Deep understanding of global regulatory requirements (FDA CFRs, ICH guidance, EU Annex)
• Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and LMS
• Strong strategic and operational capability with hands-on execution skills
• Exceptional written and verbal communication skills

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for FSHD and Pompe disease.