Director/Sr. Director QA

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 ResponsibilitiesBuild and implement the company's GxP Quality Management SystemProvide QA oversight for GMP manufacturing activities and documentationManage quality oversight of CDMOs, vendors, and external service providersLead supplier quality management, audits, and quality agreementsDrive risk management, issue escalation, and quality improvement processesSupport quality strategy across development and manufacturing programsQualifications~12+ years of quality experience in biotech or pharmaceutical environmentsStrong expertise in cGMP and global regulatory expectationsExperience establishing or scaling quality systems in emerging companiesBackground supporting external manufacturing and CDMO partnershipsExperience preparing for or supporting regulatory inspections preferredStartup or early-stage biotech experience is a plusPlease reach out to s.viall@kennedybond.com for more information.