Global QMS Director - Scale Compliance for Growth

Initial Therapeutics, Inc.; Waltham (MA); On-site; USD 196,000 - 230,000; Full time

Job summary

Dyne Therapeutics, Inc. is seeking a Director, Quality Management Systems, based in Waltham, MA. This role is essential for designing and advancing the Quality Management System to support our transition to commercial operations.

Key responsibilities include ensuring compliance readiness, leading internal audits, and driving operational excellence within the quality framework. Candidates should have over 10 years of relevant experience and strong leadership skills. A Bachelor's degree in a scientific discipline is required, with an advanced degree preferred.

Qualifications

• 10+ years of experience in biotechnology or pharmaceutical environments.
• Direct ownership of QMS and quality systems.
• Demonstrated leadership experience.

Responsibilities

• Design and scale a global Quality Management System.
• Lead risk-based internal audit programs.
• Drive continuous improvement initiatives for the QMS.

Skills

Leadership in QMS

Regulatory understanding (FDA, ICH)

Risk management

Communication skills

Operational excellence

Education

Bachelor’s degree in scientific discipline or Quality Systems Management

Advanced degree preferred

Tools

eQMS platforms (e.g., Veeva eQMS, MasterControl)

Job description

Dyne Therapeutics, Inc. is seeking a Director, Quality Management Systems, based in Waltham, MA. This role is essential for designing and advancing the Quality Management System to support our transition to commercial operations.

Key responsibilities include ensuring compliance readiness, leading internal audits, and driving operational excellence within the quality framework. Candidates should have over 10 years of relevant experience and strong leadership skills. A Bachelor's degree in a scientific discipline is required, with an advanced degree preferred.