Director of QA GMP Operations at Dyne Therapeutics

Location: Waltham, Massachusetts
Type: Full-time
Posted: Jun 10, 2026

Description

The Director of QA GMP Operations at Dyne Therapeutics manages global external and internal GMP quality operations for drug development and commercialization. This includes overseeing QA activities, ensuring quality of deliverables, managing deviations and investigation, reviewing documentation, supporting tech transfer and process validation, and handling batch disposition.

Required Skills

GMP quality management
cGMP principles
ICH guidelines
regulatory sections of IND/IMPD and BLA/MAAs
Tech Transfer
Process Validation

Additional Information

Preferred Qualifications: Experience in managing external quality operations for GMP manufacturing.
Ability to manage deviation, out-of-specification (OOS), and out-of-trend (OOT) investigations according to cGMP and ICH guidelines.
Proficiency in reviewing batch records, analytical method reports, and technical documents, particularly those containing regulatory sections like IND/IMPD and BLA/MAAs.
Support for technology transfer and process validation initiatives.
Responsibility for batch disposition and interaction with Qualified Persons (QPs).