Jobs in Saugus, MA

A small clinical-stage RNAi biotech is seeking a Director of Quality Assurance to build and lead a fit-for-purpose GxP quality function while overseeing global CDMO manufacturing and vendor quality operations.

**Role requires Wednesday through Friday onsite in Boston.

Key Responsibilities

• Build and implement the company’s GxP Quality Management System
• Provide QA oversight for GMP manufacturing activities and documentation
• Manage quality oversight of CDMOs, vendors, and external service providers
• Lead supplier quality management, audits, and quality agreements
• Drive risk management, issue escalation, and quality improvement processes
• Support quality strategy across development and manufacturing programs

Qualifications

• ~12+ years of quality experience in biotech or pharmaceutical environments
• Strong expertise in cGMP and global regulatory expectations
• Experience establishing or scaling quality systems in emerging companies
• Background supporting external manufacturing and CDMO partnerships
• Experience preparing for or supporting regulatory inspections preferred
• Startup or early-stage biotech experience is a plus

Please reach out to for more information.