Director of Quality Assurance - Nusano

Position Summary:

At Nusano, we are working to empower the world’s leading companies, health care providers, and innovators with the radioisotopes needed to advance cancer care. Our state-of-the-art facility in West Valley City, Utah will produce radioisotopes quickly, efficiently, and affordably. This will make desperately needed resources available to hospitals and cancer clinics around the world and offer those with life-threatening diseases hope for a healthier tomorrow.

We are seeking a Director of Quality Assurance with experience leading a quality team in a drug product environment. At Nusano, quality is a fully integrated function, engaged from development through commercialization of products and across disciplines. This position will oversee the maturation of the quality system and quality 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 maintain a culture of robust risk management, including supporting inspection readiness of facilities and senior leadership’s role within the Quality Management System.

What You'll Do:

• Leadership and Engagement
  • Provides leadership and support to the Quality Assurance staff, ensuring that written delegation of authority and clear delineation of areas of responsibilities exist for all Quality Assurance functions.
  • Maintains consistent alignment and communication with Quality Assurance and Nusano Senior Leadership.
  • Ensures cross-disciplined leadership engagement through a periodic management review process to support sound decisions of stakeholders.

• Quality Assurance Systems
  • Ensures that the corporate quality policy is consistent with risk management concepts discussed by regulatory agencies, primarily through Federal Regulations (CFR), Guidance from the Food and Drug Administration (FDA), and International Conference on Harmonization (ICH), as adapted for isotope production.
  • Maintains an effective and well-designed Quality Management System (QMS) that is consistent with a corporate quality policy, is anchored on patient safety and product quality, and is reflective of product development stage and intended use.
  • Maintains the phase-appropriate (pre-clinical, IND, NDA/BLA) levels of controls on documentation that supports design, development, manufacturing, and distribution of Nusano products.

• Regulatory Communications
  
  • Facilitates communications with Nusano departments, functions, external regulatory agencies (worldwide), consultants, and various stakeholders that impact the development and maintenance of regulatory filings, in coordination with Regulatory Affairs. 

• Quality Compliance
  
  • Leads and supports risk management reviews, such as thorough documentation change control and engineering change control.
  • Ensures regulatory agency site inspection readiness, through internal audits, mock inspections, documentation check lists, team risk assessment reviews, and other tools as deemed appropriate.
  • Supports regulatory agencies inspection activities, remote and onsite, ensuring logistical support, information flow, staff readiness and assignments, and leadership engagement as necessary.
  • Manages the activities of contractors and consultants supporting the Quality Assurance team.
  • Ensures training programs are in place across quality and the organization.
  • Audits contract research organizations, contract manufacturing organizations, contract laboratories, critical vendors, and suppliers to ensure a proper level of compliance.
  • Ensures that production activities are performed and controlled through written instructions.
  • Ensure that process deviations are consistently and properly investigated.
  • Ensure that all products released by or for Nusano for clinical and commercial purposes meet established quality criteria provided to regulatory agencies.

Minimum Requirements:

• B.S. degree in a life sciences related field, such as chemistry or biology.
• Minimum of 7+ years of experience in the pharmaceutical industry leading a quality team comprised of quality assurance and compliance.
• Experience with various stages of product life cycles (pre-commercial/post-commercial).
• Direct experience with FDA onsite inspections and other regulatory agencies, including post-inspection management.
• Experience with eQMS deployment and management.
• Experience interfacing with engineering, chemistry/laboratories, product development, technical operations, and validations.
• Familiar with quality review processes and interface with senior leadership presentations.
• Proficient with Microsoft Office software.
• Strong verbal and written communication skills.

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 interface with FDA via multiple modes, i.e. in-person, teleconference, emails.
• Familiar with export/import activities relevant to isotopes.

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 and/or GMP.
• Must be able to sit for long periods of time.
• Frequent use of computer with repetitive use of keyboard, mouse, and manual dexterity.
• Ability to travel domestically and internationally up to 15% of the time.

About Nusano:

No patient should be denied the cancer care they need simply because some options are in short supply or unavailable. Yet, all too often, this is what happens.

Nusano is a medical technology company that creates radioisotopes used to target and eliminate cancer cells with precision. Health care has used radioisotopes to diagnose and treat cancer and other diseases for decades. But, if supply does not keep up with demand, patients will lose out on the benefits of these lifesaving, proven tools.

Nusano’s patented technologies and methods are poised to transform radioisotope production and usher in an exciting new era in cancer care. Our state-of-the-art facility in West Valley City, Utah will produce radioisotopes quickly, efficiently, and affordably. This will make desperately needed resources available to hospitals and cancer clinics around the world and offer those with life-threatening diseases hope for a healthier tomorrow.

• Comprehensive medical, dental, and vision coverage for employees and their eligible dependents
• Stock Options
• 401(K) Retirement Plan
• Company-paid life insurance & AD&D coverage
• Company-paid short-term disability coverage
• Healthcare Flexible Spending Account (FSA)
• Dependent Care Reimbursement Account (DCRA)
• Voluntary Life Insurance
• Employee Assistance Program (EAP)
• Vacation, Sick Time, and Holidays