Quality Systems Manager - TPI

TITLE: Quality Systems Manager - TPI

LOCATION: Everett, WA

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 Systems Manager – TPI

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, customer, and internal audits). Collaborate to resolve audit findings and track follow-up actions to closure.

- Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement.

- 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.

Key Qualifications and Skills

- Bachelor’s degree in a life sciences discipline or a related field (or equivalent qualification through experience).

- Minimum of 12 years of experience in either a QA function or a combination of quality assurance and radiopharmaceutical manufacturing under cGMP requirements.

- Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus.

- 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.

- Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements.

- 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. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.

- 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.

- 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.

- The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Job Functions

Job Functions are physical actions and/or working conditions associated with the position. These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation. Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations. An applicant's ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations, including but not limited to any governing safety standards.

- Motor Abilities: Sitting and standing for extended periods, bending/stooping, grasping/gripping, fine motor control (hands).

- Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds.

- Repetitive work: Prolonged.

- Special Senses: Visual and audio focused work and ability to perform role in personal protective equipment.

- Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./day.

- Travel required 10-20%

TerraPower’s technology is controlled for export by various agencies of the U.S. Government. TerraPower must evaluate applicants who are foreign nationals (other than asylees, refugees, or lawful permanent residents) in accordance with U.S. Government export control requirements. To facilitate TerraPower’s export control reviews, you will be asked as part of the application process to identify whether you are a U.S. Citizen or national, asylee, refugee, or lawful permanent resident of the United States. Government export authorization approval times vary. Based on the business needs for a particular position, TerraPower may not consider a foreign national from a country if it is impracticable to obtain timely Government export approval.

Job details

Salary Range Level 12: $168,316 - $252,475

- We typically place offers in the lower to middle portion of the range to maintain internal equity and allow room for growth. Any salary offered within the posted salary band is based on market data and commensurate with the selected individual’s qualifications experience. This range is specific to Washington State.

Benefits:

- Competitive Compensation

- Salary, eligible to participate in discretionary short-term incentive payments

- Comprehensive Medical and Wellness Benefits for family or individual

o Vision

o Dental

o Life

o Life and Disability

o Gender Affirmation Benefits

o Parental Leave

- 401k Plan

- Generous Paid Time Off (PTO)

o 21 days of annually accrued PTO

- Generous Holiday Schedule

o 10 paid holidays

- Relocation Assistance

- Professional and Educational Support Opportunities

- Flexible Work Schedule

TerraPower Career and Benefits information: https://www.terrapower.com/contact-us/careers/