Quality Assurance Manager, TerraPower Isotopes

TerraPower•Everett, WA

16d•$168,316 - $252,475•Onsite

About The Position

TerraPower Isotopes (TPI™) 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. TPI currently produces actinium-225 for the growing alpha therapy market and intends to expand. The TerraPower Isotopes (TPI) business 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. TPI 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 Isotopes (TPI) is seeking an experienced Quality Assurance Manager to support Ac-225 production at the Everett manufacturing facility. The Quality Assurance Manager will be responsible for 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 Assurance Manager will be responsible for Quality oversight of the production activities to enable production of Active Pharmaceutical Ingredient (API) Starting Material consistent with pharmaceutical industry requirements. The Quality Assurance Manager will report to the Director, Quality and work closely with a multidisciplinary team including site Quality Systems, Operations, Quality Control, Engineering, R&D, Procurement, and Project Management teams.

Requirements

Bachelor’s degree in a life sciences discipline or a related field (or equivalent qualification through experience).
12+ years of experience in either a QA function or a combination of quality assurance and radiopharmaceutical manufacturing under cGMP requirements.
Demonstrated experience working within Quality Systems (compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance) and providing collaborative customer support. Experience in a production radiopharmaceutical facility is preferred.
Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
Strong attention to detail, with the ability to interpret federal regulations, guidance, and standards.
Proven ability to develop, mentor, and grow team members, including setting clear expectations, providing constructive feedback, and supporting career development.
Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Nice To Haves

Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus.
Strong troubleshooting, analytical, and problem-solving skills, such as those developed in fast-paced environments including the military, and other nuclear or radiopharmaceutical environments is highly preferred.

Responsibilities

Manage Quality Assurance team in the development and implementation of the quality programs for TPI.
Accountable for end-to-end Quality oversight of production activities, batch record review and approval and product and material disposition.
Provide QA resources for technology transfer and scale-up activities in support of production expansion initiatives.
Author, revise, and manage the approval of site policies and procedures related to Quality. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
Communicate quality objectives and requirements to company management and co-workers with a goal to foster a company-wide quality culture.
Support the implementation of quality systems, including QMS, EDMS, and LMS.
Develop and lead implementation of audit program (supplier, customer, and internal audits). Collaborate to resolve audit findings and track follow-up actions to closure.
Support the development and implementation of data integrity policies and a comprehensive risk management program aligned with ICH Q9 guidelines.
Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement.
Participate in team interactions with customers, representing quality.
Balance Quality requirements with safety, such as radiation safety, in all Quality initiatives.
Lead and develop teams by fostering collaboration, aligning priorities with organizational goals, and creating a positive, inclusive work environment that promotes growth and innovation.