Quality Assurance Manager

Company: Niowave
Location: Chicago
Posted on: May 4, 2025

Job Description:

We are a group of scientists, engineers, designers, technicians, and others dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We also enjoy darts, cornhole, ping-pong, group lunches, chili cook-offs, and other fun events that foster a community where we make a life, not just a living.
Who you are---
You are a seasoned professional inspired by developing team members to reach their potential. You thrive on helping others succeed and influencing patient outcomes through quality practices. Your job satisfaction comes from fostering collaboration and synergy in cross-functional teams, enabling them to achieve optimal outcomes. You promote a "seek first to understand" environment and celebrate both the journey and the destination. You view leadership as a privilege and responsibility to positively impact others' lives.
How you will make an impact---
The Quality Assurance Manager leads and manages a team of nuclear engineers and health physicists. You will develop and oversee team and individual KPIs, ensuring effective coordination, communication, and success in project outcomes aligned with company objectives.
What you need to succeed---

• 
  
• Bachelor's degree or equivalent in Science/Engineering or related field.
  
• 8+ years of experience in quality, compliance, manufacturing operations within GMP pharmaceutical or radioisotope manufacturing.
  
• 5+ years managing daily activities of five or more team members, with proven ability to build cohesive teams, establish career development paths, and succession plans.
  
• Strong analytical and problem-solving skills with data-driven risk management abilities.
  
• Excellent interpersonal, written, and oral communication skills.
  
• Organizational and project management skills for self and teams.
  
• Ability to handle multiple priorities and meet deadlines.
  
• Proven leadership and staff development skills.
  
• Ability to work effectively in a team-oriented, collaborative environment.
  
• Alignment with Niowave Values: Teamwork, Courage, Integrity, Upright Zeal.
  
• Understanding of team integration, including respecting current processes and pacing improvements appropriately.
  
• Self-awareness of communication and learning styles, with the ability to adapt and connect with others.
  
• Deep understanding of Quality Systems and successful implementation, with knowledge of GMP and related pharmaceutical regulations.
  
  Great to have---
  
  • 
    
  • Master's degree in science/engineering or equivalent experience.
    
  • 10+ years of Quality Assurance experience in a cGMP manufacturing environment.
    
  • Experience with radioactive materials.
    
  • Proficiency with analytical tools like Minitab or JMP.
    
  • Experience managing medium to large-scale projects.
    
  • Knowledge of 21 CFR Part 212, ICH Q7-Q12, NRC regulations, or similar compliance experience.
    
  • Full-time availability.
    
  • Flexibility to work outside standard hours as needed, with understanding of shift requirements.
    
  • Willingness to travel between multiple Lansing area locations.
    
    Application Note
    Please include a cover letter detailing your interest and expertise.
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Keywords: Niowave, Janesville , Quality Assurance Manager, Executive , Chicago, Wisconsin