Quality Systems Manager

Overview

Position Summary:

At Nusano, Quality is a fully integrated function, engaged from development through commercialization. This Quality Systems Manager will support the maturation of the quality systems and team to maintain ongoing quality compliance with the Food and Drug Cosmetic Act and associated regulations, in support of isotope production for expanding medical needs. This role will help maintain a culture of robust risk management, supporting inspection readiness of facilities and senior leadership’s role within the Quality Management System.

What You ll Do:

Leadership and Engagement

• Support the leadership, mentorship, supervision and development of the Quality Assurance staff.
• Maintain consistent alignment and communication with Quality Assurance and Nusano Leadership.
• Drive a culture of quality and compliance throughout the organization.

Quality Assurance Systems

• Oversee controlled documents (SOPs, policies, forms, templates) and ensure proper review, approval, distribution, and archival.
• Manage records retention schedules in compliance with applicable regulations.
• Develop and manage training programs, curricula, and tracking systems.
• Ensure training compliance and maintain training records for all GxP staff.
• Administer and review change requests, ensuring proper impact assessment, approvals, and timely closure.
• Ensure Corrective and Preventive Actions are logged, investigated, and implemented effectively.
• Oversee initiation, investigation, and closure of deviations and nonconformances.
• Act as system owner for eQMS platforms, including deployment, validation, and periodic review.
• Implement continuous improvement initiatives to enhance efficiency and compliance across QA processes.
• Support supplier and vendor qualification activities in collaboration with the Compliance QA Manager.

Minimum Requirements:

• Bachelor’s degree in a life science related field, such as chemistry or biology.
• 10+ years in Quality Assurance within a GMP-regulated environment, and with a minimum of 5 years in leadership positions.
• Ability to manage multiple priorities and work in a fast-paced environment.
• Proficient with Microsoft Office software.
• Strong verbal and written communication skills.
• Experience with various stages of product life cycles (pre-commercial/post-commercial).
• Experience with eQMS deployment and management.
• Experience interfacing with engineering, chemistry/laboratories, product development, technical operations.

Preferred Requirements:

• Experience with radiopharmaceuticals or isotopes.
• Awareness of accelerator (cyclotron, LINAC) processes.
• Familiarity with DOT, NRC, DOE and other regulatory agency requirements.
• Familiarity with radiopharmaceutical development, injectable drug products, and European regulations.
• Direct experience with FDA or other health authority inspections.
• Experience with implementation and validation of eQMS
• Experience with on-site FDA inspections and management of response cycles.
• Professional certifications: ASQ-CQA, ASQ-CMQ/OE

Physical Requirements:

• Work to be conducted in an office environment, laboratories, engineering R&D, and/or production environment.
• Must be comfortable working within radiation environments and/or GMP.
• Must be able to sit for long periods of time.
• Frequent use of computers with repetitive use of keyboard, mouse, and manual dexterity.
• Ability to travel domestically and internationally up to 10% of the time.

About Nusano:

At Nusano, we believe in the power of innovation to enhance lives and strengthen the communities we serve. We are more than a physics company; we are pioneers in the production of both medical and industrial isotopes. Our mission is to ensure that high-quality radioisotopes are readily available for critical applications, from cancer treatment to advancing space exploration, and enabling other groundbreaking innovations.

Our state-of-the-art facility in West Valley City, Utah will harness our proprietary ion source technology to produce isotopes efficiently and sustainably. We understand the urgent need for reliable access to these vital resources, and we are committed to leading the way in supply stability and innovation. We envision…