Quality Compliance Manager

Nusano•West Valley City, UT

About The Position

Overview Position Summary: The Quality Compliance Manager will be part of a fully integrated Quality function at Nusano, engaged from development through commercialization. The Quality Compliance Manager supports the maturation of quality systems and the team to maintain ongoing compliance with the Food and Drug Cosmetic Act and associated regulations, in support of isotope production for expanding medical needs. This role helps maintain a culture of robust risk management, supporting inspection readiness of facilities and senior leadership’s role within the Quality Management System. Responsibilities What You'll Do: 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 regulatory compliance and inspection readiness throughout the organization. Authoring new and updating existing procedures. Design and implement new paper-based Quality Management System (QMS) processes, such as Non-Conformance, CAPA, and Risk Management and assume ownership of these processes. Transition these processes to an electronic QMS platform, ensuring successful implementation and ongoing management of electronic workflows. Conduct risk management assessments. Lead inspection readiness activities including internal audits, mock inspections, and documentation reviews. 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 for compliance and completeness. Ensure that qualification and validation activities meet established compliance standards. Support regulatory submissions and responses to health authority inquiries in collaboration 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 a life science related field, such as chemistry or biology. 10+ years in Quality Assurance within a GMP-regulated environment, 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. Writing new cGMP compliant procedures. 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. 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 a future where no patient has to face treatment delays due to shortages, and where industries can thrive with dependable access to the materials they need. At Nusano, we are dedicated to making a meaningful impact, not only in healthcare but also in the broader community. We strive to empower our partners and customers, ensuring that together, we can build a healthier, more vibrant tomorrow for all. 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

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, 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.
Writing new cGMP compliant procedures.
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 regulatory compliance and inspection readiness throughout the organization.
Authoring new and updating existing procedures.
Design and implement new paper-based Quality Management System (QMS) processes, such as Non-Conformance, CAPA, and Risk Management and assume ownership of these processes.
Transition these processes to an electronic QMS platform, ensuring successful implementation and ongoing management of electronic workflows.
Conduct risk management assessments.
Lead inspection readiness activities including internal audits, mock inspections, and documentation reviews.
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 for compliance and completeness.
Ensure that qualification and validation activities meet established compliance standards.
Support regulatory submissions and responses to health authority inquiries in collaboration with Regulatory Affairs.
Define and monitor compliance metrics to assess the effectiveness of QA processes.
Provide compliance and inspection readiness training across the organization.

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