Quality Assurance Manager
Who we are…
We are a group of scientists, engineers, designers, technicians, and many others who are dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We also enjoy darts, cornhole, ping-pong, take-out for group lunches, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.
Who you are…
You are a seasoned professional who is inspired by developing team members to reach their greatest potential. You are energized by helping others succeed and by the opportunity to influence patient outcomes through deliberate quality practices. Your job satisfaction is measured by collaboration and synergy you instill in cross-functional team members, enabling them to achieve optimal outcomes. You model a “seek first to understand” environment and celebrate the journey as well as the destination. You wholeheartedly embrace leadership as a choice, a responsibility, and a remarkable privilege to positively impact the lives of others.
How you will make an impact…
The Quality Assurance Manager is responsible for the leadership and management of a team of quality professionals. The Quality Assurance Manager develops and manages team and individual Key Performance Indications (KPIs), ensures succinct coordination, communication, and ultimate success with desired project outcomes and meeting company objectives.
What you need to succeed…
- Bachelor’s degree or equivalent in Science/Engineering or a related field.
- 8+ years of experience in quality, compliance, manufacturing operations within a GMP pharmaceutical or radioisotope manufacturing setting.
- 5+ years’ experience managing day-to-day activities of five or more team members, with demonstrated ability to build cohesive teams, establish career development tracks, and succession planning.
- Analytical and problem-solving skills with the ability to critically interpret and use data to manage risk.
- Excellent interpersonal, written, and oral communication skills.
- Organizational and project management skills for self and teams.
- Ability to manage multiple priorities simultaneously while meeting deadlines.
- Proven ability to lead and develop staff and teams.
- Expertly performs in a team-oriented, collaborative environment.
- Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal.
- Understands how to integrate into a new team/organization – appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.
- Understands your own communication and learning styles, can assess others’ styles, and is able to find the right path to connect the two.
- Strong understanding and experience in Quality Systems and their successful implementation; Substantive knowledge of applicable GMP and related pharmaceutical manufacturing regulations.
Great to have…
- Master’s degree in science/engineering field or equivalent experience
- 10+ years of Quality Assurance experience operating in a cGMP manufacturing environment.
- Experience with radioactive material.
- Experience with Minitab, JMP or other analytical tools.
- Previous medium to large scale project management experience.
- Knowledge of 21 CFR Part 212 and ICH Q7-Q12, Nuclear Regulatory Commission (NRC) regulations or similar regulatory compliance experience.
Work Environment
- Full-time position.
- The company’s standard operating hours are Monday thru Friday 6a – 6p with production related activities requiring 24/7/365 shifts.
- This position will have regular working hours during M – F with an expectation of adjusting to work outside of the standard operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Please provide a cover letter specifically describing the nature of your interest & expertise.
