Senior QMS Director, Global Compliance & Training

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

Job summary

Dyne Therapeutics in Waltham, MA is seeking an Associate Director, Quality Management Systems to design and scale a global QMS supporting commercial operations. You will own document control, records, and training, ensuring inspection readiness and alignment with ICH Q10, FDA CFRs, and international standards.

This hands-on role combines strategic vision with daily execution, partnering across functions to embed quality as a driver of business performance while maintaining scalable, compliant

Qualifications

• Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred.
• 8+ years in biotechnology or pharmaceutical environments with GxP exposure.
• Direct ownership of QMS and quality systems.
• Experience implementing eQMS platforms and Learning Management Systems.
• Strong strategic and operational capability with hands-on execution.

Responsibilities

• QMS Strategy, Compliance & Inspection Readiness across global operations.
• Lead the evolution of QMS to a commercial-ready, scalable system.
• Ensure QMS processes are risk-based and phase-appropriate.
• Govern the eDMS and LMS with validated systems and governance.
• Provide SME leadership during regulatory inspections and audits.
• Define metrics, drive continuous improvement, and sustain quality culture.

Skills

Quality management

Cross-functional leadership

Regulatory knowledge

Education

Bachelor's degree in science or Quality Systems Management

Advanced degree preferred

Tools

Veeva eQMS

MasterControl

LMS

Job description

Dyne Therapeutics in Waltham, MA is seeking an Associate Director, Quality Management Systems to design and scale a global QMS supporting commercial operations. You will own document control, records, and training, ensuring inspection readiness and alignment with ICH Q10, FDA CFRs, and international standards.

This hands-on role combines strategic vision with daily execution, partnering across functions to embed quality as a driver of business performance while maintaining scalable, compliant