Position Summary

The Quality Compliance Manager is a key member of Nusano’s integrated Quality function, supporting development through commercialization. The Quality Compliance Manager advances quality systems and ensures compliance with FDA and cGMP regulations for isotope production used in the diagnosis and treatment of cancer. You will play a critical role in driving a culture of risk management and inspection readiness across the Quality Management System (QMS), helping ensure the safe, reliable delivery of products that support life-saving medical care.

Responsibilities

What You'll Do:

• Lead and develop QA staff while aligning with Quality and company leadership
• Drive regulatory compliance, risk management, and inspection readiness across the organization
• Author and maintain cGMP procedures
• Design, implement and own QMS processes, (Non-Conformance, CAPA, Risk Management), including eQMS transition and management
• Lead audits and inspection readiness activities; host regulatory inspections
• Serve as point-of-contact and host for regulatory agency inspections, managing logistics, information flow, and staff readiness
• Conduct supplier audits to ensure compliance with quality agreements and regulatory standards.
• Oversee review of executed manufacturing and testing records and ensure qualification/validation compliance
• Support regulatory submissions and responses with Regulatory Affairs
• Define and monitor compliance metrics to assess the effectiveness of QA processes
• Provide compliance and inspection readiness training across the organization
  
  

Qualifications

Minimum Requirements:

• Bachelor’s degree in life science related field, such as chemistry or biology
• 7+ years of QA 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
• Experience writing cGMP-compliant procedures
• Strong verbal and written communication skills, with the ability to interface with engineering, laboratories, product development, and technical operations
• Experience with eQMS deployment and management
  
  

Preferred Requirements:

• Experience with radiopharmaceuticals or isotopes
• Familiarity with 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 implementing and validating 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 comfortable working within radiation environments
• Must be able to sit for long periods of time.
• Frequent use of computers with repetitive use of keyboard, mouse, and manual dexterity
  
  

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.