Job Information
TerraPower Quality Assurance Manager, TerraPower Isotopes in Everett, Washington
Title: Quality Assurance Manager, TerraPower Isotopes Location: Everett, Washington The 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. Quality Assurance Manager - TPI TerraPower is seeking a Quality Assurance Professional to join a forward-thinking team of professionals who will prepare and distribute life-saving radioisotopes intended for use in targeted cancer therapy. The Quality Assurance Manager for TerraPower Isotopes is responsible for leading a quality program to enable production of Active Pharmaceutical Ingredient (API) Starting Material consistent with pharmaceutical industry requirements. The candidate leads a quality team and reports directly to the Division President. The ideal candidate has extensive experience in development and management of Quality programs for API, Drug Substance or Drug Product. Experience in compliance with Current Good Manufacturing Practices for pharmaceuticals and FDA Part 210/211 is required. Experience with ISO 9001 quality requirements is a plus. Due to international distribution of product, experience with ICH and other international standards for quality of pharmaceutical ingredients is desired. The successful candidate should have extensive experience in development of quality programs, supplier evaluation and qualification, and commercial supply chain requirements for time-sensitive products. Responsibilities: Lead the TPI quality team and represent quality on the division's management team. Manage and execute a quality management program consistent with pharmaceutical manufacturer requirements for API starting material. Execute and enhance quality aspects of project-specific plans to support company goals. Participate in overall company initiatives to apply quality principles to procedures and standards. Review design specifications, procedures, and other technical documents for quality, supporting company initiatives. Oversee Change Control for TPI processes subject to Quality requirements. Communicate quality objectives and requirements to company management and co-workers with a goal to foster a company-wide culture of compliance. Develop personnel training related to quality and good manufacturing practices. Oversee implementation and training of a Laboratory Information Management System (LIMS)<