Global QMS & Compliance Leader (Associate Director)

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

Job summary

Dyne Therapeutics in Waltham, MA, seeks an Associate Director, Quality Management Systems to design, scale, and advance a global QMS supporting a move to commercial operations.

The role leads document control, records management, and training programs, ensuring inspection readiness and compliance with ICH, FDA CFRs, and EU Annex requirements, while partnering across functions to embed quality as a strategic driver.

Qualifications

• Bachelor’s degree in a scientific discipline or Quality Systems Management is required.
• 8+ years of experience in biotechnology or pharmaceutical environments with GxP exposure.
• Direct ownership of QMS and quality systems.
• Experience with eQMS platforms (Veeva eQMS, MasterControl) and LMS.
• Strong written and verbal communication for senior stakeholders.

Responsibilities

• Lead evolution of QMS to commercial-ready, globally scalable system.
• Ensure phase-appropriate, risk-based QMS processes.
• Represent QMS during regulatory inspections.
• Oversee document management and training programs in eDMS/LMS.
• Define quality metrics and drive continuous improvement.
• Collaborate with cross-functional partners to embed quality in processes.

Skills

QMS ownership

Regulatory knowledge

Cross-functional leadership

Strategic thinking

Education

Bachelor’s degree in science or Quality Systems Management

Tools

Veeva eQMS

MasterControl

Job description

Dyne Therapeutics in Waltham, MA, seeks an Associate Director, Quality Management Systems to design, scale, and advance a global QMS supporting a move to commercial operations.

The role leads document control, records management, and training programs, ensuring inspection readiness and compliance with ICH, FDA CFRs, and EU Annex requirements, while partnering across functions to embed quality as a strategic driver.