The Quality Assurance (QA) Manager will be responsible for designing and implementing a Quality Assurance program for the Immunotherapy Coordinating Center (ICC) at Seattle Children's Research Institute. The ICC serves as a sponsor organization for early phase pediatric cellular immunotherapy clinical trials. Will oversee single and multi-site, Phase I and II trials spanning multiple clinical programs across several pediatric hospitals in North America. The QA Manager will lead the development, establishment, and maintenance of quality assurance systems, including, but not limited to, the development of a Quality Management System for the ICC, coordination and management of internal and external audits, document control systems, SOP administration and development, and training records and activities. The QA Manager will serve as a subject matter expert, and provide mentorship, leadership and guidance for quality assurance to the organization. The QA Manager will also provide leadership and management of a combined Regulatory Affairs and Quality Assurance functional area, including IND submissions and safety reporting.
- Bachelor’s Degree in a life science or a related field.
- Management/supervisory experience, minimum of two years.
- Minimum of seven (7) years experience in the pharmaceutical industry, commercial clinical research organization or academic setting.
- Minimum of five (5) years of experience working in a Quality or GCP Compliance-related role.
- 10+ years working in a Quality or GCP Compliance role.
- Master’s Degree in biological sciences or health-related field.
- Regulatory Affairs experience, particularly with IND applications.
- Experience interacting with the FDA or other health authority agencies.