Nusano · 2 days ago
Quality Systems Manager
West Valley City, UT
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expNusano is a pioneering company in the production of medical and industrial isotopes. The Quality Systems Manager will oversee quality compliance and systems, supporting the maturation of quality processes and ensuring adherence to regulations in isotope production.
BiotechnologyHealth CareHealth DiagnosticsMedicalNuclearPharmaceuticalTherapeutics
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
Qualification
Required
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
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
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
Company
Nusano
Nusano is a physics firm that produces radioisotopes, tiny tracers doctors use to diagnose and cure cancer and other ailments.
51-200 employees
H1B Sponsorship
Nusano has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageTotal Funding
$115MKey Investors
Wasatch Group
2024-10-01Series C· $115M
2018-10-24Series A
Leadership Team
Aimee Edwards
Head of Global Policy and Public Affairs
Jzaneen Damji
Chief Business Officer
Recent News
2025-12-12
2025-12-08
Company data provided by crunchbase