Associate Director, Global QMS & Compliance

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

Job summary

Dyne Therapeutics is seeking an Associate Director of Quality Management Systems in Waltham, MA. You will design, scale, and advance a global QMS that supports commercial operations, with responsibility for document control, records management and training.

This hands-on leadership role requires strategic vision and operational execution to ensure inspection readiness and regulatory alignment. You will partner cross-functionally to embed quality as a strategic enabler, oversee policy and SOP

Qualifications

• Bachelor’s degree in a scientific discipline or Quality Systems Management.
• 8+ years in biotechnology or pharmaceutical environments with exposure to GxP.
• Direct ownership of QMS and quality systems.
• Deep understanding of FDA CFRs, ICH guidance, EU Annex requirements.
• Experience implementing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Lernning Management Systems.
• Strong strategic and hands-on execution capability.
• Ability to manage multiple complex initiatives in a fast-paced environment.
• Excellent written and verbal communication; autonomous work style.

Responsibilities

• Lead the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international standards.
• Ensure QMS processes are phase-appropriate, risk-based, and scalable.
• Act as SME for QMS during regulatory inspections and health authority interactions.
• Provide leadership for GxP documentation and training, utilizing eDMS and LMS.
• Oversee end-to-end lifecycle management of policies, SOPs, and records.

Skills

GxP experience

Regulatory knowledge

Leadership

Communication

Education

Bachelor’s degree in a scientific discipline or Quality Systems Management

Tools

Veeva eQMS

MasterControl

LMS

Job description

Dyne Therapeutics is seeking an Associate Director of Quality Management Systems in Waltham, MA. You will design, scale, and advance a global QMS that supports commercial operations, with responsibility for document control, records management and training.

This hands-on leadership role requires strategic vision and operational execution to ensure inspection readiness and regulatory alignment. You will partner cross-functionally to embed quality as a strategic enabler, oversee policy and SOP