Director, Quality Management Systems
Dyne Therapeutics
5 days ago
Remote friendly (Waltham, MA)
United States
Operations
Role Summary
The Director, Quality Management Systems is a hands-on quality leader responsible for designing, scaling, and advancing a global Quality Management System (QMS) to support Dyne’s transition to commercial operations.
Primary Responsibilities Include
QMS Strategy, Compliance & Inspection Readiness
- Lead 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 scalable
- Establish and sustain a proactive compliance model to support continuous inspection readiness
- Serve as subject matter expert and primary representative during regulatory inspections and health authority interactions
Core QMS Program Ownership
- Lead a risk-based internal audit program (planning, execution, follow-up)
- Identify systemic quality risks; ensure CAPA development, closure, and effectiveness checks
- Build and mature a risk-based supplier quality program (qualification, monitoring, oversight)
- Oversee end-to-end product complaint management (intake, triage, investigation, escalation, trending) for scalable commercial distribution
Operational Excellence & Systems Enablement
- Define, monitor, and report quality metrics and KPIs
- Drive continuous improvement to enhance efficiency and reduce risk
- Lead implementation/optimization/governance of eQMS platforms with validated systems and lifecycle management
Cross-Functional Leadership & Quality Culture
- Embed quality into business processes via cross-functional partnerships
- Communicate quality risks and tradeoffs clearly to influence outcomes
- Model accountability, transparency, and continuous improvement
Education and Skills Requirements
- Bachelor’s degree in scientific discipline or Quality Systems Management (advanced degree preferred)
- 10+ years in biotechnology/pharmaceutical environments with GxP exposure (GCP/GLP/GMP/GVP preferred)
- Demonstrated leadership with direct QMS/quality systems ownership
- Deep understanding of global regulatory requirements (FDA CFRs, ICH guidance, EU Annex)
- Proven eQMS platform and Learning Management Systems experience (e.g., Veeva eQMS, MasterControl)
- Strong strategic/operational balance, risk management, multitasking, and autonomy
- Exceptional written/verbal communication to influence senior stakeholders
MA Pay Range
- $196,000 - $230,000 USD
The Director, Quality Management Systems is a hands-on quality leader responsible for designing, scaling, and advancing a global Quality Management System (QMS) to support Dyne’s transition to commercial operations.
Primary Responsibilities Include
QMS Strategy, Compliance & Inspection Readiness
- Lead 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 scalable
- Establish and sustain a proactive compliance model to support continuous inspection readiness
- Serve as subject matter expert and primary representative during regulatory inspections and health authority interactions
Core QMS Program Ownership
- Lead a risk-based internal audit program (planning, execution, follow-up)
- Identify systemic quality risks; ensure CAPA development, closure, and effectiveness checks
- Build and mature a risk-based supplier quality program (qualification, monitoring, oversight)
- Oversee end-to-end product complaint management (intake, triage, investigation, escalation, trending) for scalable commercial distribution
Operational Excellence & Systems Enablement
- Define, monitor, and report quality metrics and KPIs
- Drive continuous improvement to enhance efficiency and reduce risk
- Lead implementation/optimization/governance of eQMS platforms with validated systems and lifecycle management
Cross-Functional Leadership & Quality Culture
- Embed quality into business processes via cross-functional partnerships
- Communicate quality risks and tradeoffs clearly to influence outcomes
- Model accountability, transparency, and continuous improvement
Education and Skills Requirements
- Bachelor’s degree in scientific discipline or Quality Systems Management (advanced degree preferred)
- 10+ years in biotechnology/pharmaceutical environments with GxP exposure (GCP/GLP/GMP/GVP preferred)
- Demonstrated leadership with direct QMS/quality systems ownership
- Deep understanding of global regulatory requirements (FDA CFRs, ICH guidance, EU Annex)
- Proven eQMS platform and Learning Management Systems experience (e.g., Veeva eQMS, MasterControl)
- Strong strategic/operational balance, risk management, multitasking, and autonomy
- Exceptional written/verbal communication to influence senior stakeholders
MA Pay Range
- $196,000 - $230,000 USD