Who we are…
We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, 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…
Words that describe you include collaborator, clear communicator, and solutions focused. You are steady, thoughtful, and principled. Safety and quality aren’t checkboxes for you; they are personal standards. You believe excellence is built through discipline, clarity, and consistency, and you naturally model that for others. People trust you because you are credible, calm, and fair. You are energized by supporting a savvy team that serves every part of the organization. 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.
What you can expect to work on…
The Quality Assurance Supervisor is responsible for overseeing quality processes to ensure that all products manufactured at Niowave adhere to established standards and regulatory requirements, thereby maintaining a high level of customer satisfaction. This role involves supervising individuals working on projects ranging from process improvements, test method development and validation, The Quality Assurance team ensures that changes to suppliers, processes, equipment, system, methods and materials are properly documented, tested, and released according to internal and regulatory requirements.
- Reviews and approves documents and records in support of manufacturing, including validation documents, protocols, final reports, and study design
- Serves as an SME on method development and validation in line with Quality by Design principals and ICHQ1-Q14
- Serves as a member of the Change Review Board
- Leads investigation teams
- Represents QA in internal and external audits
- Analyze documentation and perform gap assessments
- Manages team resources and scheduling to support scale-up and product improvement activities
- Coordinates with key stakeholders in the organization to ensure objectives are met and staff are properly developed and trained
- Collaborates effectively with a cross functional team to meet objectives and complete key initiatives
- Leads and inspires a diverse team of skilled professionals
- Establishes and maintains a technical direction and supervisory oversight structure for the team, including career progression and succession planning
- Within the department and across the organization, fosters a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization
What you need to succeed…
- Embraces and models the Niowave Core 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 best connect with colleagues
- Bachelor’s degree or equivalent in science, engineering, management, or related field
- 8+ years of relevant experience in quality, compliance, or MS&T within a GMP pharmaceutical or radioisotope manufacturing setting
- 3+ years of experience managing day-to-day activities of 6 or more team members, with demonstrated ability to build cohesive teams, establish career development tracks, and succession planning
- Displays proven ability to lead and develop staff and teams
- Experience operating in a cGxP environment with the ability to apply best practices
- Subject matter expertise product and process development, Quality by Design, and regulatory expectations.
- Hands-on experience utilizing root cause analysis and continuous improvement systems (Six Sigma, Lean Manufacturing, 5S, statistical analysis and process control, process and value stream mapping, 5-Whys, fishbone/Ishikawa diagram, A3 Problem Solving)
- Displays excellent interpersonal, written, and oral communication skills
- Possesses strong organizational and project management skills for self and teams
- Demonstrates strategic thinking with creative and excellent problem solving and decision-making skills with ability to critically interpret and use data to manage risk
Great to have…
- Master’s degree in science, engineering, management, or related field
- 10+ years of relevant experience in quality, compliance, or manufacturing within a GMP pharmaceutical or radioisotope manufacturing setting
- Experience with radioactive material
- Experience with Minitab, JMP, or other analytical tools
- Previous medium to large scale project management experience
- Knowledge of one or more of the following regulations: 21CFR 210& 211, Nuclear Regulatory Commission (NRC)
Other things to know…
- Full-time position
- Niowave’s standard operating hours are Monday – Friday 6:00 a.m. – 6:00 p.m. with production related activities requiring 24/7/365 shifts
- This position will have regular working hours Monday – Friday with an expectation of adjusting to meet shift work requirements and to engage with staff working outside of standard hours as needed
- Niowave has multiple locations within the Lansing area and travel between locations is expected in the role
Please provide a cover letter specifically describing the nature of your background and experience as it relates to this position.
