Hiring: Associate Director, Quality Management Systems Company: Dyne Therapeutics Location: Waltham, MA Job Posted Time: 2026-09-10 13:16:42 Target Skills & Keywords : GCP, Risk Management About the job Experience: •8+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred) Required Skills: •The Associate Director, Quality Management Systems is a key member of the quality team responsible for designing, scaling, and advancing a global Quality Management System (QMS) that supports Dyne’s transition to commercial operations. •This role is responsible for key elements of the QMS including document control, records management and training ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations. Qualifications: •Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred •Demonstrated experience with direct ownership of QMS and quality systems •Comprehensive expertise in global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements •Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems •Strong strategic and operational capability, balancing vision-setting with hands-on execution •Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment •Strong judgment and risk management skills, balancing compliance, science, and business needs •Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders •Highly proactive, accountable, and comfortable operating with a high degree of autonomy Compensation: •$160,000 - $195,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!