Senior Director, Quality Control — GMP Strategy

Initial Therapeutics, Inc.; Waltham (MA); On-site; USD 240,000 - 285,000; Full time

Job summary

Dyne Therapeutics seeks a Senior Director, Quality Control to lead strategy and execution of QC across clinical and commercial manufacturing. You will ensure global GMP compliance, inspection readiness, and robust analytics with external testing labs, including release and stability programs.

The role partners with contract manufacturers and cross-functional teams to drive quality, lifecycle management, and regulatory readiness in a fast-paced, matrixed environment.

Qualifications

• Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field.
• Advanced degree in chemistry, analytical chemistry, or related discipline is preferred.
• 15+ years of experience in Analytical Development and Quality Control, with leadership responsibilities.

Responsibilities

• Define and execute the Quality Control strategy aligned with quality and business objectives.
• Represent QA/QC during regulatory inspections and ensure inspection readiness.
• Author, review, and approve CMC content in regulatory submissions (IND, BLA, and MAAs).
• Oversee external testing labs, release and stability testing, and COAs.
• Lead investigations for out-of-specification events with root-cause analysis and corrective actions.
• Build QC capabilities in data analysis, stability, and statistical methods.

Skills

GMP knowledge

Quality Control leadership

Regulatory submissions

Contract labs management

Analytical development

Data integrity

Education

Bachelor’s degree in biology, analytical chemistry, biochemistry, or related field

Advanced degree in chemistry, analytical chemistry, or related discipline

Job description

Dyne Therapeutics seeks a Senior Director, Quality Control to lead strategy and execution of QC across clinical and commercial manufacturing. You will ensure global GMP compliance, inspection readiness, and robust analytics with external testing labs, including release and stability programs.

The role partners with contract manufacturers and cross-functional teams to drive quality, lifecycle management, and regulatory readiness in a fast-paced, matrixed environment.