Quality Systems Manager – TPI

Quality Systems Manager – TPI

LOCATION:

Everett, WA

The Terra Power Isotopes® (TPI™) division has been established to pursue medical isotopes development–advancing nuclear science for significant human health benefits. We seek to support revolutionary radio therapies for treatments of various cancers through the supply of radioisotopes. Terra Power 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 Terra Power Isotopes (TPI) program is an integral part of the Washington State based Terra Power 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. Terra Power’s mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field.

Terra Power 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.

Terra Power 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, Terra Power has instituted an AAP to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.

• Direct a team of Quality staff in the development and implementation of the Quality Program for TPI.
• Lead the implementation, qualification, and maintenance of quality systems, including QMS, EDMS, and LMS.
• Author, revise, and manage the approval of site policies and procedures related to Quality.
• Oversee the development and implementation of data integrity policies to ensure the accuracy, reliability, and compliance of all data generated within the organization.
• Design, implement, and maintain a comprehensive risk management program aligned with ICH Q9 guidelines.
• Participate in Quality System audits (supplier, customer, and internal audits). Collaborate to resolve audit findings and track follow-up actions to closure.
• 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.
• Lead and develop teams by fostering collaboration, aligning priorities with organizational goals, and creating a positive, inclusive work environment that promotes growth and innovation.

• Bachelor’s degree in a life sciences discipline or a related field (or equivalent qualification through experience).
• Minimum of 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.
• Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements.
• 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. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
• Proven ability to develop, mentor, and grow team members, including setting clear expectations, providing constructive feedback, and…