Director, Quality Management Systems
Dyne Therapeutics
June 27, 2026
Remote friendly (Waltham, MA)
United States
Operations
Role Summary
- Hands-on Director, Quality Management Systems responsible for designing, scaling, and advancing a global Quality Management System (QMS) to support Dyne’s transition to commercial operations.
- Based in Waltham, MA.
Primary Responsibilities
QMS Strategy, Compliance & Inspection Readiness
- Lead evolution of a commercial-ready, globally scalable QMS aligned with ICH Q10 and FDA CFRs.
- Ensure QMS processes are phase-appropriate, risk-based, and scalable.
- Establish and sustain a proactive compliance model for continuous inspection readiness.
- Serve as subject matter expert during regulatory inspections and health authority interactions.
Core QMS Program Ownership
- Lead risk-based internal audit program (planning, execution, follow-up).
- Identify systemic quality risks; ensure timely CAPA development, closure, and effectiveness checks.
- Build/mature risk-based supplier quality program (qualification, monitoring, oversight).
- Oversee end-to-end product complaint management (intake, triage, investigation, escalation, trending).
Operational Excellence & Systems Enablement
- Define/monitor quality metrics and KPIs.
- Drive continuous improvement to enhance efficiency and reduce risk.
- Lead eQMS platform implementation/optimization/governance.
Cross-Functional Leadership & Quality Culture
- Embed quality into business processes; communicate risks/impacts clearly.
- Model accountability, transparency, and continuous improvement.
Education & Skills Requirements
- Bachelor’s in scientific discipline or Quality Systems Management (advanced degree preferred).
- 10+ years in biotech/pharma; exposure across GxPs (GCP/GLP/GMP/GVP preferred).
- Proven QMS/quality leadership and ownership.
- Deep regulatory knowledge (FDA CFRs, ICH, EU Annex).
- Experience with eQMS (e.g., Veeva eQMS, MasterControl) and learning management systems.
- Strong strategic/operational execution, risk judgment, and communication; high autonomy.
MA Pay Range
- $196,000 - $230,000 USD
- Hands-on Director, Quality Management Systems responsible for designing, scaling, and advancing a global Quality Management System (QMS) to support Dyne’s transition to commercial operations.
- Based in Waltham, MA.
Primary Responsibilities
QMS Strategy, Compliance & Inspection Readiness
- Lead evolution of a commercial-ready, globally scalable QMS aligned with ICH Q10 and FDA CFRs.
- Ensure QMS processes are phase-appropriate, risk-based, and scalable.
- Establish and sustain a proactive compliance model for continuous inspection readiness.
- Serve as subject matter expert during regulatory inspections and health authority interactions.
Core QMS Program Ownership
- Lead risk-based internal audit program (planning, execution, follow-up).
- Identify systemic quality risks; ensure timely CAPA development, closure, and effectiveness checks.
- Build/mature risk-based supplier quality program (qualification, monitoring, oversight).
- Oversee end-to-end product complaint management (intake, triage, investigation, escalation, trending).
Operational Excellence & Systems Enablement
- Define/monitor quality metrics and KPIs.
- Drive continuous improvement to enhance efficiency and reduce risk.
- Lead eQMS platform implementation/optimization/governance.
Cross-Functional Leadership & Quality Culture
- Embed quality into business processes; communicate risks/impacts clearly.
- Model accountability, transparency, and continuous improvement.
Education & Skills Requirements
- Bachelor’s in scientific discipline or Quality Systems Management (advanced degree preferred).
- 10+ years in biotech/pharma; exposure across GxPs (GCP/GLP/GMP/GVP preferred).
- Proven QMS/quality leadership and ownership.
- Deep regulatory knowledge (FDA CFRs, ICH, EU Annex).
- Experience with eQMS (e.g., Veeva eQMS, MasterControl) and learning management systems.
- Strong strategic/operational execution, risk judgment, and communication; high autonomy.
MA Pay Range
- $196,000 - $230,000 USD