Quality Assurance Manager, TerraPower Isotopes®

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Job Description

Title: Quality Assurance Manager, TerraPower Isotopes®

Location: Everett, Washington

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 Assurance Manager – TPI

TerraPower is seeking a Quality Assurance Professional to join a forward-thinking team of professionals who will prepare and distribute life-saving radioisotopes intended for use in targeted cancer therapy. The Quality Assurance Manager for TerraPower Isotopes is responsible for leading a quality program to enable production of Active Pharmaceutical Ingredient (API) Starting Material consistent with pharmaceutical industry requirements. The candidate leads a quality team and reports directly to the Division President.

The ideal candidate has extensive experience in development and management of Quality programs for API, Drug Substance or Drug Product. Experience in compliance with Current Good Manufacturing Practices for pharmaceuticals and FDA Part 210/211 is required. Experience with ISO 9001 quality requirements is a plus. Due to international distribution of product, experience with ICH and other international standards for quality of pharmaceutical ingredients is desired. The successful candidate should have extensive experience in development of quality programs, supplier evaluation and qualification, and commercial supply chain requirements for time-sensitive products.

Responsibilities:

  • Lead the TPI quality team and represent quality on the division’s management team.
  • Manage and execute a quality management program consistent with pharmaceutical manufacturer requirements for API starting material.
  • Execute and enhance quality aspects of project-specific plans to support company goals.
  • Participate in overall company initiatives to apply quality principles to procedures and standards. Review design specifications, procedures, and other technical documents for quality, supporting company initiatives. Oversee Change Control for TPI processes subject to Quality requirements.
  • Communicate quality objectives and requirements to company management and co-workers with a goal to foster a company-wide culture of compliance.
  • Develop personnel training related to quality and good manufacturing practices.
  • Oversee implementation and training of a Laboratory Information Management System (LIMS)
  • Oversee batch record approval process, responsible manager for quality attributes of batch.
  • Lead and coordinate customer and regulatory agency audit/inspections of TPI operations related to quality. Direct the resolution of findings and follow-up.
  • Participate in team interactions with customers, representing quality.
  • Signatory to Quality Agreements associated with Supply Agreements.
  • Manage Corrective and Preventive Action (CAPA) program, Continuous Improvement initiatives, Risk Management, and Out-of-Specification Investigations.
  • Manage the audit program, including regular internal audits and a supplier audit program.
  • Other responsibilities to support company initiatives.

Key Qualifications and Skills

  • BS or graduate degree in a quality assurance-related field or a technical discipline which includes quality requirements. Extensive equivalent QA experience in a pharmaceutical discipline may be considered as a substitute for academic degree.
  • Minimum 12 years of experience in either a QA function or combination of quality assurance and radiopharmaceutical manufacturing under CGMP requirements.
  • Current certification in a Pharmaceutical Quality-related discipline is a plus.
  • The ideal candidate will have experience working in quality program development for manufacture of API, API starting material, or pharmaceutical ingredients.
  • Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards.
  • Must have experience with CAPA, Root Cause Analysis, Continuous Improvement, and OOS investigations.
  • Strong written and oral communications skills are required.
  • Understand the principles of radiation safety and apply worker safety considerations to procedures, with the guidance of TerraPower radiation safety experts. Training in radiation safety is provided for the successful candidate who has no experience in this technical area.
  • Demonstrated success in managing a team of technical professionals and interacting with peers, collaborating toward successful completion of common goals.
  • High degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.
  • Military experience is a plus.
  • Actual position starting level and title will be determined on assessment of qualifications.

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 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/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: 0-20%

TerraPower’s 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 TerraPower’s 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

Salary Range Level 12: $157,405 - $218,119

*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 candidate’s 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
  • 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
  • Flexible Work Schedule

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

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