Lead and develop teams by fostering collaboration, aligning priorities with organizational goals, and creating a positive, inclusive work environment that promotes growth and innovation.
Design, implement, and maintain 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.
Balance Quality requirements with safety, such as radiation safety, in all Quality initiatives.
Oversee the development and implementation of data integrity policies to ensure the accuracy, reliability, and compliance of all data generated within the organization.
Lead the implementation, qualification, and maintenance of quality systems, including QMS, EDMS, and LMS.
Direct a team of Quality staff in the development and implementation of the Quality Program for TPI.
Author, revise, and manage the approval of site policies and procedures related to Quality.
Participate in Quality System audits (supplier, customer, and internal audits). Collaborate to resolve audit findings and track follow-up actions to closure.
Requirements
cgmp
csv
six sigma
bachelor's
12 years
problem solving
Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds.
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.
Motor Abilities: Sitting and standing for extended periods, bending/stooping, grasping/gripping, fine motor control (hands).
The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.
Repetitive work: Prolonged.
Travel required 10-20%
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.
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.
Minimum of 12 years of experience in either a QA function or a combination of quality assurance and radiopharmaceutical manufacturing under cGMP requirements.
Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus.
Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements.
Bachelor’s degree in a life sciences discipline or a related field (or equivalent qualification through experience).
Proven ability to develop, mentor, and grow team members, including setting clear expectations, providing constructive feedback, and supporting career development.
Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
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.
Benefits
Generous Paid Time Off (PTO)
Gender Affirmation Benefits
Salary, eligible to participate in discretionary short-term incentive payments
21 days of annually accrued PTO
Life and Disability
Flexible Work Schedule
10 paid holidays
Competitive Compensation
Generous Holiday Schedule
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.
Relocation Assistance
401k Plan
Comprehensive Medical and Wellness Benefits for family or individual
Parental Leave
Professional and Educational Support Opportunities
Training + Development
Information not given or found
Interview process
Information not given or found
Visa Sponsorship
Information not given or found
Security clearance
Information not given or found
Company
Overview
Founded with a vision to revolutionize the nuclear energy sector and reduce global carbon emissions.
Develops advanced nuclear reactors, such as Natrium, designed for clean, safe, and efficient energy generation.
Focused on utilizing next-generation technology to solve the world’s energy challenges sustainably.
Pioneers in the use of innovative fuel designs, including Natrium’s molten salt technology.
Natrium reactor design offers unique features, like the ability to integrate with renewable energy sources.
Supported by top-tier investors, including Bill Gates and Warren Buffett, to accelerate energy transition.
Aims to deploy advanced nuclear reactors globally, contributing to a low-carbon future.
Combines decades of expertise in nuclear engineering with cutting-edge technology to ensure safety and performance.
Recent partnerships with governments and private sectors to bring next-gen nuclear solutions to market.
Culture + Values
Driven by a mission to deliver sustainable, carbon-free energy by using nuclear energy as a key solution.
Committed to providing innovative, reliable, and scalable nuclear technology to meet the world’s growing demand for clean energy.
Value collaboration and recognize that solving the energy challenges of today and tomorrow requires the collective efforts of diverse and dedicated people.
Embrace transparency and integrity in every aspect of our work, ensuring accountability and fostering trust.
Take pride in a culture of safety and innovation, continuously improving to create a world-class team focused on results.
Environment + Sustainability
Contribute to the global transition to clean, carbon-free energy.
Working toward deploying next-gen nuclear reactors with advanced fuel cycles.
Natrium reactor complements renewable energy sources and reduces emissions.
Technology aims to recycle spent nuclear fuel, reducing waste.
Inclusion & Diversity
The company fosters a diverse and inclusive environment where all team members are empowered to thrive.
The company is committed to recruiting a diverse workforce and building teams that reflect a wide range of perspectives.
The company is actively investing in gender equality within its teams, but specific gender-related statistics are not publicly disclosed.
Tips: The company provides resources to support the professional growth of all employees.