Director/Sr. Director QA
Kennedy Bond, Boston, MA, United States
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.
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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.
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