QMS Director, Global Compliance & Readiness

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

Job summary

Dyne Therapeutics seeks an Associate Director of Quality Management Systems to design, scale, and advance a global QMS aligned with ICH Q10 and global regulatory expectations. The role is hands-on and strategic, partnering across functions to embed quality as a business enabler in preparation for commercial operations.

The successful candidate will lead document control, records management, and training programs, ensuring inspection readiness while scaling to support growth in a fast-paced

Qualifications

• Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred.
• 8+ years of biotech/pharma experience with exposure across GxPs (GCP, GLP, GMP, GVP preferred).
• Demonstrated experience with direct ownership of QMS and quality systems.
• Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements.
• Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems.
• Strong strategic and operational capability, balancing vision-setting with hands-on execution.
• Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment.
• Strong judgment and risk management skills, balancing compliance, science, and business needs.
• Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders.
• Highly proactive, accountable, and comfortable operating with a high degree of autonomy.

Responsibilities

• Lead the evolution of the QMS to a commercial-ready, globally scalable system.
• Ensure QMS processes are phase-appropriate, risk-based, and scalable with growth.
• Maintain proactive compliance and inspection readiness.
• Represent QMS during regulatory inspections and health authority interactions.
• Provide strategic and operational leadership for GxP documentation and training programs (eDMS/LMS).
• Oversee end-to-end lifecycle management of quality documents (policies, SOPs, records).
• Drive high-volume document authoring, revision, and implementation under accelerated timelines.
• Lead training curriculum planning and deployment across functions.
• Develop engaging learning materials and assessments for quality programs.
• Lead scale efforts for eDMS/LMS capabilities with validated systems.
• Define and report quality metrics and KPIs; drive continuous improvement and risk reduction.
• Govern eQMS platforms to ensure adoption and lifecycle management.
• Partner with cross-functional stakeholders to embed quality into processes.

Skills

GxP knowledge

QMS ownership

Regulatory understanding

eQMS platforms

LMS implementation

Strategic execution

Multi-project management

Risk management

Written and verbal communication

Autonomy

Education

Bachelor’s degree in scientific discipline or Quality Systems Management

Advanced degree preferred

Tools

Veeva eQMS

MasterControl

Job description

Dyne Therapeutics seeks an Associate Director of Quality Management Systems to design, scale, and advance a global QMS aligned with ICH Q10 and global regulatory expectations. The role is hands-on and strategic, partnering across functions to embed quality as a business enabler in preparation for commercial operations.

The successful candidate will lead document control, records management, and training programs, ensuring inspection readiness while scaling to support growth in a fast-paced