Supervisor, Quality Assurance – Operations; 2nd shift

Overview

Join the best radiopharmaceutical company in the world!

If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, North Star Medical Radioisotopes is the place to do it. North Star Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

At the forefront of North Star’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life‑saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world‑class facilities and a competitive benefits package.

The Quality Assurance Operations Supervisor leads daily QA activities to ensure compliance with GMP regulations and company quality standards. This role supports and directs the QA team, manages day‑to‑day operations, and ensures issues are resolved quickly and effectively. The supervisor is responsible for training, coaching, and evaluating staff while promoting a culture of quality and continuous improvement. The position also oversees key quality processes such as investigations, CAPA, and change management, maintains audit readiness, supports inspections, and drives improvements in processes and efficiency.

Projects and duties will be completed in compliance with applicable regulatory agency standards.

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Lead and coordinate day‑to‑day Quality Assurance operations and team activities.
• Supervise, coach, train, and develop QA staff to ensure compliance and performance expectations are met.
• Assign, prioritize, and monitor work to support departmental objectives and operational needs.
• Conduct regular team meetings, provide feedback, and complete performance evaluations for direct reports.
• Ensure team compliance with GMP requirements, quality systems, procedures, and applicable regulations.
• Oversee timely completion of investigations, CAPAs, change controls, and other quality system activities.
• Maintain audit readiness and support responses to internal and external audit findings.
• Promote a culture of quality, compliance, accountability, and continuous improvement.
• Identify and implement improvements to quality processes, systems, and operational efficiency.
• Monitor quality metrics and support risk management and continuous improvement initiatives.
• Coordinate with QA Operations to ensure that development programs and projects can be implemented efficiently and cost effectively within the operational environment.

After 3 months you will:

• Understand Quality Assurance Operations roles and responsibilities as they apply to radiopharmaceutical manufacturing.
• Complete Radiation Training for Building access.
• Review, approve and ensure timely closure of quality documentation
• Provide QA oversight and operational support during manufacturing activities

After 6 months you will:

• Independently review, approve and provide oversight for Document Change Orders (DCO) and Change Requests (CR) impacting operations and quality system documentation
• Oversee final Batch release, and completion/approval of CoA (Certificate of Analysis)
• Lead and review investigations of quality events
• Demonstrate independent decision‑making and leadership during production activities ensuring compliance, product quality, and efficient issue resolution

MINIMUM EDUCATION/

EXPERIENCE:

Bachelor’s degree in chemistry, Biology, or other related scientific discipline with a minimum of six (6) years of GMP‑related experience in biopharmaceutical, pharmaceutical, or related industry with direct quality experience; or equivalent combination of education and experience. One…