Job Description
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 s.viall@kennedybond.com for more information.
Disclaimer: This job listing is sourced from LinkedIn and is provided for informational purposes. Apply directly through the employer’s application process. Medical Device Navigator is not affiliated with the hiring company.