Director, Quality Management Systems

Role: The Director of Quality Management Systems leads the development and scaling of Dyne's global QMS to support transition to commercial operations. Responsibilities include evolving the QMS aligned with international standards (ICH Q10, FDA CFRs), ensuring phase-appropriate and risk-based processes, maintaining inspection readiness, and serving as subject matter expert during regulatory interactions. Ownership spans internal audits, CAPAs, supplier quality oversight, and product complaint lifecycle management, with a focus on scalability for commercialization. The role emphasizes operational excellence through quality metrics, continuous improvement, and eQMS platform management. It also entails cross-functional partnership to embed quality culture and drive strategic initiatives. Qualifications: Bachelor’s in a scientific or Quality Systems field; 10+ years in biotech/pharma, with GxP experience (GMP, GCP, GLP, GVP preferred); proven leadership with quality systems; deep knowledge of global regulatory requirements; experience with eQMS platforms like Veeva or MasterControl; strong strategic, operational, and communication skills; high autonomy. High-value specifics include a focus on compliance, inspection readiness, and scalable quality systems supporting biomolecular and cell/gene therapies in late-stage development and commercialization. Location: Waltham, MA.