Quality Systems Manager - TPI

Quality Systems Manager - TPI

TerraPower Isotopes (TPI) division has been established to pursue medical isotopes development advancing nuclear science for significant human health benefits. We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes. TerraPower currently has unique access to a supply of thorium for the long-term production of actinium-225 in the growing alpha therapy market and intends to expand into other nuclear related medical treatments. The TerraPower Isotopes (TPI) program is an integral part of the Washington State based TerraPower team, a company working to raise living standards globally. In 2006, the company originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world. TerraPower's mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field. TerraPower is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced radiopharmaceutical applications and influencing change within nuclear medicine. TerraPower is an Equal Opportunity Employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. In addition, as a federal contractor, TerraPower has instituted an Affirmative Action Plan (AAP) to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.

TerraPower Isotopes (TPI) is seeking an experienced Quality Systems Manager to support Ac-225 production at the Everett manufacturing facility. The Quality Systems Manager will play a critical role in establishing, developing, and maintaining robust quality systems to ensure alignment with Good Manufacturing Practices (GMP), regulatory guidelines (FDA Title 21 CFR 210 / 211 and ICH Guidance), radiation safety, and company policies. This position will focus on onboarding and qualifying new systems, creating and optimizing procedures, developing training programs, and driving implementation of key quality initiatives. The Quality Systems Manager will oversee the Quality Management System (QMS), Electronic Document Management System (EDMS), Learning Management System (LMS) and training program, Quality Risk Management (QRM) program, and data integrity policies and will operate under stringent FDA and NRC regulations. The Quality Systems Manager will report to the Senior Manager Quality Assurance and work closely with a multidisciplinary team including site Quality Assurance, Operations, Analytics, Engineering, R&D, Procurement, and Project Management.

Responsibilities :

• Direct a team of Quality staff in the development and implementation of the Quality Program for TPI.
• Lead the implementation, qualification, and maintenance of quality systems, including QMS, EDMS, and LMS.
• Author, revise, and manage the approval of site policies and procedures related to Quality.
• Oversee the development and implementation of data integrity policies to ensure the accuracy, reliability, and compliance of all data generated within the organization.
• Design, implement, and maintain a comprehensive risk management program aligned with ICH Q9 guidelines.
• Participate in Quality System audits (supplier, custome