Quality Assurance Manager, TerraPower Isotopes

Title: Quality Assurance Manager TerraPower Isotopes

Location: Everett Washington

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 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. TerraPowers 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 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.

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.

Key Qualifications and Skills

Bachelors 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.

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.

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.

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 our 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 applicants 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/or standing for extended periods. Bending/stooping grasping/gripping fine motor control (hands). Keyboard focused activities.

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

Repetitive work: Prolonged computer use.

Special Senses: Visual and audio-focused work.

Work conditions: Stairs typing/keyboard standard and/or sitting working environment of >8 hours per day.

Travel required: 10-20%

TerraPowers technology is controlled for export by various agencies of the US Government. TerraPower must evaluate applicants who are foreign nationals (other than asylees refugees or lawful permanent residents) in accordance with US Government export control requirements. To facilitate TerraPowers export control reviews you will be asked as part of the application process to identify whether you are a US 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

Job Type: Full-time

Salary Range Level 12: $168316- $252475

*Typically our employee salaries are within .90 1.0 of the mid-point of the posted salary bands. Any salary offered within the posted salary band is based on market data and commensurate with the selected candidates qualifications and 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 Medical

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

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