Global Head of Quality Control & Compliance

Dyne Tx; Waltham (MA); Hybride; USD 240 000 - 285 000; Plein temps

Résumé du poste

Dyne Therapeutics in Waltham, MA seeks Senior Director, Quality Control to lead QC strategy and operations across clinical and commercial manufacturing, ensuring GMP compliance and inspection readiness. This role collaborates with contract labs and internal units to support product lifecycle management.

Based onsite in Waltham, you will advance analytical data review, stability testing, and regulatory submissions, while guiding a team through change controls, CAPAs, and data integrity

Qualifications

• Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field.
• Advanced degree in chemistry, analytical chemistry, or a related discipline is preferred.
• 15+ years of experience in Analytical Development and Quality Control, or equivalent with leadership experience.
• Strong GMP QC background with assays for antibodies and small molecules.
• Knowledge of GMP, ICH, FDA, and EU regulations.
• Experience overseeing contract testing laboratories, method lifecycle, release and stability programs, and inspection readiness.
• Experience supporting regulatory submissions and reviews of analytical CMC content.
• Experience establishing drug substance/product specifications, stability programs, reference standards, and lab compliance systems.
• Strong data integrity, change controls, CAPAs, and OOS/OOT investigations.
• Ability to set direction, manage interdependencies, and influence senior stakeholders.

Responsabilités

• Define and execute the QC strategy aligned with quality and business objectives.
• Ensure contract labs meet global GMP requirements and maintain inspection readiness.
• Represent QC during regulatory inspections.
• Prepare analytical CMC sections for IND/BLAs/MAA submissions.
• Evaluate tools for data review, statistics, stability, and expiry assignments.
• Lead Specification and Stability Review Boards and ensure timely decisions.
• Oversee analytical method transfers, qualifications, and validations.
• Manage external testing laboratories, release and stability testing, COAs.
• Review environmental monitoring, sterility, bioburden, endotoxin data.

Connaissances

GMP quality control

Contract labs management

Data integrity

Regulatory submissions support

Cross-functional leadership

Formation

Bachelor’s degree in biology/analytical chemistry/biochemistry

Advanced degree preferred

Description du poste

Dyne Therapeutics in Waltham, MA seeks Senior Director, Quality Control to lead QC strategy and operations across clinical and commercial manufacturing, ensuring GMP compliance and inspection readiness. This role collaborates with contract labs and internal units to support product lifecycle management.

Based onsite in Waltham, you will advance analytical data review, stability testing, and regulatory submissions, while guiding a team through change controls, CAPAs, and data integrity