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[QA/QC Manager] QA Compliance Manager

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TerraPower® is a nuclear energy technology company based in Bellevue, Washington. At our core, we are working to raise living standards globally. The essential factor? Energy. In 2006, Bill Gates and a group of like-minded visionaries decided that the private sector needed to take action. They believed that business interests could develop a scalable, sustainable, low-carbon and cost-competitive energy source that would allow all nations to quicken their pace of economic development and reduce poverty. TerraPower’s goal is to provide the world with a more affordable, secure and environmentally friendly form of nuclear energy.

TerraPower, LLC was established to bring together the strengths and experience of the world’s public and private nuclear energy sectors to develop a new generation of nuclear reactors that would responsibly meet growing energy needs around the globe. Its approach addresses the traditional shortcomings of nuclear power, in terms of safety, cost effectiveness, environmental soundness, and resistance to weapons proliferation.

TerraPower is seeking to contract with, via agency vendor, highly motivated and forward thinking professionals who are interested in focusing on advanced nuclear reactor research and development, and influencing change within the nuclear power landscape. 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) in an effort to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.

Targeted Alpha Therapy (TAT) Regulatory/Compliance Quality Assurance Manager

The Regulatory/Compliance QA Manager reports to the Director, Environmental, Safety, Health & Quality (ESH&Q) with a dotted line to the TAT project team. This position is responsible for management of the Quality Assurance and Quality Control activities of TerraPower’s Targeted Alpha Therapy program. The ideal candidate will be an NQA-1 Certified Lead Auditor (or other industry recognized lead auditor certification) have management experience in a regulated environment such as NRC, FDA, FAA, etc.; and have experience with direct management of QA and QC professionals.

Key Competencies and Responsibilities

Maintain the Pharmaceutical Quality System Manual to current FDA / ICH and/or cGMP standards
Representative of the TAT Quality System to customers and regulatory authorities
Develop Requirements Matrix for TAT program
Keep Senior Management informed of the status of the Quality System
Manage CAPA, Continuous Improvement and Risk Management processes associated with the TAT program
Manage internal and external (supplier) audits
Manage QC inspections
Manage source surveillance/source verification
Mentor/train prospective lead auditors and QC inspection personnel
Provide direct management and development of TAT project quality assurance and quality control related staff
Develop or review quality assurance and quality control procedures
Review other TAT quality affecting procedures (engineering, procurement, document control, records, testing)
Review procurement specifications, purchase orders, task orders and agreements for quality assurance and quality control requirements
Review design specifications, test specifications/plans/procedures, and other technical documents for quality assurance requirements using a graded approach to quality
Manage condition reports/corrective action requests associated with the TAT program

Qualifications

Undergraduate degree or equivalent experience in a technical discipline, business, management, or quality assurance field.
10+ year’s experience in a quality assurance/quality control role in a regulated environment (FDA, NRC, DOE, etc.) with cGMP and FDA requirements experience
Current certification as NQA-1 Lead Auditor or other industry recognized certification or the ability to be certified within one year of hire
Experience successfully managing and leading a team of technical professionals
Military experience is a plus
The successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.


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