TerraPower · 17 hours ago
Quality Assurance Manager, TerraPower Isotopes
Everett, Washington, United States
Full-time
Onsite
Senior Level, Lead/Staff
$168K/yr - $252K/yr
12+ years expTerraPower Isotopes (TPI) is focused on advancing nuclear science for medical isotopes, aiming to support revolutionary cancer treatments. The Quality Assurance Manager will establish and maintain quality systems in alignment with regulatory guidelines, oversee production activities, and lead a team to enhance quality initiatives.
Clean EnergyCleanTechEnergyNuclear
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
Qualification
Required
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
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
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
Preferred
Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus
Experience in a production radiopharmaceutical facility is preferred
Benefits
Competitive Compensation
Salary, eligible to participate in discretionary short-term incentive payments
Comprehensive Medical and Wellness Benefits Medical
Vision
Dental
Life
Life and Disability
Gender Affirmation Benefits
Parental Leave
401k Plan
Generous Paid Time Off (PTO)
21 days of annually accrued PTO
Generous Holiday Schedule
10 paid holidays
Relocation Assistance
Professional and Educational Support Opportunities
Company
TerraPower
TerraPower is a nuclear energy technology firm that focuses on developing a sustainable and economic nuclear energy system.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$1.49BKey Investors
Korea Hydro & Nuclear PowerUS Department of Energy
2026-01-20Secondary Market
2025-06-18Series Unknown· $650M
2022-08-15Series A· $830M
Leadership Team
Vanessa Estupinan, MS-HRM
Human Resources Business Partner
Recent News
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