Global QMS Leader for Compliance & Inspection Readiness

Dyne Therapeutics; Waltham (MA); On-site; USD 160,000 - 195,000; Full time

Job summary

Dyne Therapeutics, based in Waltham, MA, seeks an Associate Director, Quality Management Systems to design and scale a global QMS for commercial operations. You will own document control, records management, and training, ensuring systems are inspection-ready and aligned with global regulations.

The role emphasizes strategic vision with hands‑on execution, cross‑functional leadership, and delivering scalable QMS that supports rapid organizational growth.

Qualifications

• Bachelor’s degree in science or quality systems; advanced degree preferred.
• 8+ years in biotech/pharma with GxP exposure (GCP/GLP/GMP).
• Direct ownership of QMS and quality systems.
• Strong understanding of global regulatory requirements (FDA CFRs, ICH, EU Annex).
• Experience implementing eQMS platforms and LMS.

Responsibilities

• Lead the evolution of a commercial-ready, scalable QMS.
• Ensure QMS processes are risk-based and inspection ready.
• Represent QMS in regulatory inspections and health authority interactions.
• Oversee documentation, policies, SOPs, and controlled records.
• Develop training curricula across functions and scale eDMS/LMS usage.
• Manage learning materials and assessments for quality programs.
• Drive KPIs to monitor system health and compliance risk.
• Partner with stakeholders to embed quality into business processes.

Skills

Quality systems

Regulatory knowledge

eQMS platforms

Leadership

Cross-functional collaboration

Training programs

Quality metrics

Education

Bachelor’s degree in a scientific discipline

Quality Systems Management

Advanced degree preferred

Tools

Veeva eQMS

MasterControl

Learning Management Systems (LMS)

Job description

Dyne Therapeutics, based in Waltham, MA, seeks an Associate Director, Quality Management Systems to design and scale a global QMS for commercial operations. You will own document control, records management, and training, ensuring systems are inspection-ready and aligned with global regulations.

The role emphasizes strategic vision with hands‑on execution, cross‑functional leadership, and delivering scalable QMS that supports rapid organizational growth.