- Location
- Watertown, MA
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Quality & Regulatory
- Seniority
- Director
- Source
- Lever
Description
The Associate Director, Quality Systems leads the strategy, design and continuous improvement of the Quality Management System supporting Artis BioSolutions' cell therapy, viral vector and fill-finish operations. The role owns core quality systems, including document management, change control, deviations, CAPA, training, supplier quality, and risk management. This individual will also lead audit readiness, and supplier and client audits. Throughout, it ensures these systems remain phase-appropriate, scalable and compliant with regulatory expectations.
The Associate Director builds and leads the Quality Systems team and partners closely with Technical Operations, Quality Control, Process Development and Data Technology Integrations. Through metrics, risk-based decision-making and a strong quality culture, the position enables the Quality department to support operations efficiently. In doing so, it advances Artis BioSolutions' mission of helping innovators bring life-changing therapies from bench to clinic.