Global QMS Leader: Strategy, Compliance & Scale

Dyne Tx; Waltham (MA); On-site; USD 196,000 - 230,000; Full time

Job summary

Dyne Tx is seeking a Director of Quality Management Systems to design and scale their quality programs. This role is critical in advancing compliance and inspection readiness, ensuring a commercial-ready QMS aligned with global standards.

With a focus on leadership and operational excellence, the ideal candidate will drive quality initiatives and mentor teams across functions. A scientific background and substantial experience in regulatory environments are essential for success in this role.

Qualifications

• 10+ years of experience in biotechnology or pharmaceutical environments with exposure across GxPs.
• Demonstrated ownership of QMS and quality systems.
• Deep understanding of global regulatory requirements.

Responsibilities

• Lead the evolution of the QMS into a commercial-ready system aligned with regulations.
• Oversee product complaint management lifecycle and supplier quality program.
• Define and monitor quality metrics and KPIs.

Skills

Leadership experience

Regulatory knowledge (FDA CFRs, ICH)

Risk management skills

Communication skills

Project management

Education

Bachelor’s degree in scientific discipline or Quality Systems Management

Advanced degree

Tools

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

Learning Management Systems

Job description

Dyne Tx is seeking a Director of Quality Management Systems to design and scale their quality programs. This role is critical in advancing compliance and inspection readiness, ensuring a commercial-ready QMS aligned with global standards.

With a focus on leadership and operational excellence, the ideal candidate will drive quality initiatives and mentor teams across functions. A scientific background and substantial experience in regulatory environments are essential for success in this role.