Associate Director, Quality Management Systems
Dyne Therapeutics
August 18, 2026
On-site
Waltham, MA
Operations
Role Summary
The Associate Director, Quality Management Systems is responsible for designing, scaling, and advancing a global Quality Management System (QMS) to support Dyne’s transition to commercial operations. Works cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit-for-purpose, inspection-ready, scalable, and efficient.
Primary Responsibilities
- Lead evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10 and FDA CFRs/international standards
- Ensure QMS processes are phase-appropriate, risk-based, and scalable
- Establish and sustain proactive compliance for continuous inspection readiness
- Serve as subject matter expert/primary representative for assigned QMS areas during inspections and health authority interactions
- Provide strategic and operational leadership for GxP documentation and training programs, including governance of eDMS and LMS
- Oversee end-to-end lifecycle management of quality documents (policies, SOPs, controlled records)
- Drive high-volume document authoring, revision, and implementation (often under accelerated timelines)
- Plan, deploy, and govern role-based training; design learning programs (refresher, cross-training)
- Manage day-to-day training delivery; develop and review learning materials/assessments
- Define, monitor, and report quality metrics/KPIs; drive continuous improvement
- Implement/optimize/govern validated eQMS platforms and ensure lifecycle management and user adoption
- Partner to embed quality into business processes; communicate quality risks and tradeoffs
Education & Skills Requirements
- Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred
- 8+ years in biotech/pharma with exposure across GxPs (GCP/GLP/GMP/GVP preferred)
- Direct ownership experience of QMS/quality systems
- Deep knowledge of global regulatory requirements (FDA CFRs, ICH guidance, EU Annex)
- Proven eQMS and Learning Management Systems experience (e.g., Veeva eQMS, MasterControl)
- Strong strategic/operational execution; ability to manage multiple complex initiatives
- Strong risk management, judgment, and communication with cross-functional/senior stakeholders
- Highly proactive and capable of operating autonomously
Pay Range
$160,000 - $195,000 USD
Location
Waltham, MA
The Associate Director, Quality Management Systems is responsible for designing, scaling, and advancing a global Quality Management System (QMS) to support Dyne’s transition to commercial operations. Works cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit-for-purpose, inspection-ready, scalable, and efficient.
Primary Responsibilities
- Lead evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10 and FDA CFRs/international standards
- Ensure QMS processes are phase-appropriate, risk-based, and scalable
- Establish and sustain proactive compliance for continuous inspection readiness
- Serve as subject matter expert/primary representative for assigned QMS areas during inspections and health authority interactions
- Provide strategic and operational leadership for GxP documentation and training programs, including governance of eDMS and LMS
- Oversee end-to-end lifecycle management of quality documents (policies, SOPs, controlled records)
- Drive high-volume document authoring, revision, and implementation (often under accelerated timelines)
- Plan, deploy, and govern role-based training; design learning programs (refresher, cross-training)
- Manage day-to-day training delivery; develop and review learning materials/assessments
- Define, monitor, and report quality metrics/KPIs; drive continuous improvement
- Implement/optimize/govern validated eQMS platforms and ensure lifecycle management and user adoption
- Partner to embed quality into business processes; communicate quality risks and tradeoffs
Education & Skills Requirements
- Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred
- 8+ years in biotech/pharma with exposure across GxPs (GCP/GLP/GMP/GVP preferred)
- Direct ownership experience of QMS/quality systems
- Deep knowledge of global regulatory requirements (FDA CFRs, ICH guidance, EU Annex)
- Proven eQMS and Learning Management Systems experience (e.g., Veeva eQMS, MasterControl)
- Strong strategic/operational execution; ability to manage multiple complex initiatives
- Strong risk management, judgment, and communication with cross-functional/senior stakeholders
- Highly proactive and capable of operating autonomously
Pay Range
$160,000 - $195,000 USD
Location
Waltham, MA