Global QC Director — GMP, Inspections & Analytics

dynetherapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Dyne Therapeutics seeks a Senior Director, Quality Control to lead global GMP-compliant QC strategy and execution across clinical and commercial manufacturing. You will oversee external testing labs, release and stability testing, and CMC sections in regulatory filings, ensuring inspection readiness and data integrity.

You will drive analytical method transfers, validations, and CAPA programs, mentor a high-performing team, and partner with internal stakeholders to support lifecycle management

Responsibilities

• Define and execute the Quality Control strategy in alignment with quality and business objectives.
• Ensure contract testing laboratories meet global GMP requirements and maintain inspection readiness.
• Represent Quality Control during regulatory inspections.
• Author, review, and approve analytical Chemistry, Manufacturing, and Controls sections of Investigational New Drug applications, Biologics License Applications, and Marketing Authorization Applications.

Job description

Dyne Therapeutics seeks a Senior Director, Quality Control to lead global GMP-compliant QC strategy and execution across clinical and commercial manufacturing. You will oversee external testing labs, release and stability testing, and CMC sections in regulatory filings, ensuring inspection readiness and data integrity.

You will drive analytical method transfers, validations, and CAPA programs, mentor a high-performing team, and partner with internal stakeholders to support lifecycle management