Quality Systems Manager

Nusano • West Valley City, UT

2d

About The Position

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.

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.

Nice To Haves

• 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

Responsibilities

• 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.
• 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.

Benefits

• Comprehensive medical, dental, and vision coverage for employees and their eligible dependents
• 401(K) Retirement Plan
• Company-paid life insurance & AD&D coverage
• Company-paid short-term and long-term disability coverage
• High-Deductible Health Plan (HDHP) option with company funded Health Savings Account (HSA)
• Healthcare Flexible Spending Account (FSA)
• Dependent Care Reimbursement Account (DCRA)
• Voluntary Life Insurance
• Voluntary benefits such as Critical Illness, Accident, Hospital, and Pet Insurance
• Employee Assistance Program (EAP)
• Vacation, Sick Time, and Holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level