Quality Systems Specialist

TerraPower·Everett, WA, USA·Posted July 2026

Nuclear industryUS only

About this role

TerraPower Isotopes seeks an experienced Quality Systems Specialist to establish and maintain robust quality systems for Ac-225 radioisotope production at the Everett, WA facility. You'll ensure compliance with GMP, FDA Title 21 CFR 210/211, ICH Guidance, and NRC regulations while supporting the development of advanced radiopharmaceuticals for cancer treatment.

Responsibilities

—Author, revise, and manage approval of site policies and procedures related to Quality Systems
—Develop and implement data integrity policies to ensure accuracy, reliability, and compliance of organizational data
—Support supplier qualification program, verifying compliance with quality requirements for critical materials and services
—Participate in quality system audits (supplier, customer, and internal) and collaborate to resolve findings and track closure
—Support project workstreams and continuous improvement initiatives driven by Quality
—Support implementation of Quality Management Systems (QMS), Electronic Document Management System (EDMS), and Learning Management System (LMS)
—Support development and validation/qualification of equipment, facility, and manufacturing processes
—Ensure data integrity compliance across quality systems, including ALCOA+ principles and 21 CFR Part 11 requirements
—Balance quality requirements with safety considerations, including radiation safety in all quality activities
—Provide quality-related training to colleagues and serve as a resource for quality inquiries

Qualifications

—Bachelor's degree in life sciences, engineering, or related field (or equivalent experience)
—6+ years' industry experience in a regulated production environment (ISO 9001, cGMP pharmaceutical or radiopharmaceutical)
—3+ years of prior experience in a Quality Systems role
—Strong working knowledge of quality principles with proven success managing complex projects
—Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance
—Strong attention to detail with ability to interpret federal regulations and standards
—Ability to adjust to changing priorities and schedules in a dynamic environment
—Strong interpersonal skills with ability to lead cross-functional teams
—Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting

Desired

—Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management
—Experience in a production radiopharmaceutical facility