Position Summary

At Nusano, Quality is a fully integrated function, supporting development through commercialization. The Quality Systems Manager advances quality systems and ensures compliance with FDA and cGMP regulations for isotope production used in the diagnosis and treatment of cancer. In this role, you will play a critical role in driving a culture of quality, risk management, and inspection readiness across the Quality Management System (QMS).

Responsibilities

What you'll do:

Leadership and Engagement

• Lead and develop QA staff while aligning with Quality and company leadership
• Drive a culture of quality, compliance and inspection readiness 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.
• Oversee CAPA, deviations, and nonconformances, ensuring timely investigation, resolution, and effectiveness
• Act as system owner for eQMS platforms, including deployment, validation, and periodic review.
• Drive continuous improvement initiatives to enhance efficiency and compliance across QA processes.
• Support supplier and vendor qualification activities in collaboration with Quality Manager.
  
  

Qualifications

Minimum requirements:

• Bachelor’s degree in life science (e.g. chemistry or biology)
• 7+ years of Quality Assurance experience in a GMP-regulated environment, including 3+ years in leadership
• Ability to manage multiple priorities and work in a fast-paced environment.
• Proficiency in Microsoft Office
• 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, including on-site inspections and management of response cycles
• Experience with implementation and validation of eQMS
• 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 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:

Nusano is a privately held physics company working to stabilize supply chains, advance American national security, and enable once-in-a-generation innovations in fields ranging from healthcare to nuclear energy.

Nusano is commercializing platform technologies for radioisotope production, stable isotope enrichment, and advanced separation techniques. Together, these proprietary systems and methods are poised to supply the fight against cancer and help fuel the nuclear renaissance.

Our team of innovators — bring curiosity, ingenuity, and heart to solving some of the world’s hardest problems.