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
• Lead a risk-based internal audit program, including planning, execution, and follow-up
• Identify systemic quality risks and ensure timely CAPA development and closure
• Build and mature a risk-based supplier quality program
• Oversee the end-to-end product complaint management lifecycle
• Define, monitor, and report quality metrics and KPIs
• Lead the implementation, optimization, and governance of eQMS platforms

Requirements

• Bachelor’s degree in a scientific discipline or Quality Systems Management
• 10+ years of experience in biotechnology or pharmaceutical environments
• 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 (FDA CFRs, ICH, EU Annex)
• Proven experience managing eQMS platforms (e.g., Veeva, MasterControl)
• Strong strategic and operational capability
• 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 facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.