Global QC Strategy Lead, GMP & Inspections

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

Job summary

Dyne Therapeutics seeks a Senior Director of Quality Control to lead global QC strategy and ensure GMP compliance across development, manufacturing, and lifecycle management. Based in Waltham, MA, the role is on-site and partners with contract labs and internal functions to enable product quality and regulatory readiness.

The successful candidate will drive analytical method transfers, validations, release/stability programs, and data integrity initiatives while guiding a high-performing team

Qualifications

• Bachelor's degree in biology, analytical chemistry, biochemistry, or related field.
• Advanced degree in chemistry, analytical chemistry, or related discipline preferred.
• 15+ years of experience in Analytical Development and Quality Control, with leadership experience.
• Strong GMP Quality Control background and familiarity with ICH, FDA, and EU regulations.
• Experience overseeing contract testing laboratories, analytical method lifecycle activities, release and stability programs, and inspection readiness.

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 CMC sections of IND, BLA, and MAA filings.
• Lead the authoring, review, and approval of analytical method transfers, qualifications, and validations.
• Oversee external testing laboratory operations, release and stability testing, and Certificates of Analysis.
• Review environmental monitoring, sterility, bioburden, and endotoxin data and participate in related reviews.

Skills

Leadership

Regulatory knowledge

Quality systems

Analytical development

Vendor management

Education

Bachelor's degree in biology/chemistry/biochemistry

Advanced degree preferred (MS/PhD)

Job description

Dyne Therapeutics seeks a Senior Director of Quality Control to lead global QC strategy and ensure GMP compliance across development, manufacturing, and lifecycle management. Based in Waltham, MA, the role is on-site and partners with contract labs and internal functions to enable product quality and regulatory readiness.

The successful candidate will drive analytical method transfers, validations, release/stability programs, and data integrity initiatives while guiding a high-performing team