Supervisor, Quality Assurance –Operations (2nd shift)

NorthStar Medical Technologies; Beloit (WI); On-site; USD 90,000 - 140,000; Full time

Job summary

NorthStar Medical Radioisotopes is seeking a qualified Quality Assurance Leader to supervise QA staff and ensure GMP compliance across manufacturing operations.

You will lead investigations, CAPAs, change controls, and audit readiness while driving continuous improvement and risk management within a fast-growing radiopharmaceutical environment.

Qualifications

• Bachelor’s degree in chemistry, biology, or related field with GMP experience.
• At least six years of GMP-related experience in biopharmaceutical or related industry with direct quality experience.
• One year of direct leadership experience required.
• Working knowledge of 21 CFR Parts 210, 211, and 11, and ICH guidelines.

Responsibilities

• Lead and coordinate day-to-day QA operations and team activities.
• Supervise, coach, train, and develop QA staff to ensure compliance and performance.
• Ensure team compliance with GMP requirements, quality systems, procedures, and applicable regulations.
• Oversee investigations, CAPAs, change controls, and other quality system activities.
• Maintain audit readiness and support responses to audit findings.
• Promote a culture of quality, compliance, accountability, and continuous improvement.
• Identify and implement improvements to quality processes and operational efficiency.

Skills

Quality Assurance Leadership

GMP compliance

Investigations

CAPA management

Change controls

Audits

Continuous improvement

Risk management

Education

Bachelor’s degree in chemistry/biology or related scientific discipline

Job description

Join the best radiopharmaceutical company in the world!

If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

At the forefront of NorthStar’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package.

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Lead and coordinate day-to-day Quality Assurance operations and team activities.
• Supervise, coach, train, and develop QA staff to ensure compliance and performance expectations are met.
• Assign, prioritize, and monitor work to support departmental objectives and operational needs.
• Conduct regular team meetings, provide feedback, and complete performance evaluations for direct reports.
• Ensure team compliance with GMP requirements, quality systems, procedures, and applicable regulations.
• Oversee timely completion of investigations, CAPAs, change controls, and other quality system activities.
• Maintain audit readiness and support responses to internal and external audit findings.
• Promote a culture of quality, compliance, accountability, and continuous improvement.
• Identify and implement improvements to quality processes, systems, and operational efficiency.
• Monitor quality metrics and support risk management and continuous improvement initiatives.
• Coordinate with QA Operations to ensure that development programs and projects can be implemented efficiently and cost effectively within the operational environment.

MINIMUM EDUCATION/EXPERIENCE:

Bachelor’s degree in chemistry, Biology, or other related scientific discipline with a minimum of six (6) years of GMP-related experience in biopharmaceutical, pharmaceutical, or related industry with direct quality experience; or equivalent combination of education and experience. One (1) year of direct leadership experience required. Working knowledge of applicable regulations, including 21 CFR Parts 210, 211, and 11, and ICH guidelines required.

PREFERRED EDUCATION/EXPERIENCE:

• Prior experience supervising Quality Assurance personnel in a regulated GMP manufacturing environment.
• Experience leading investigations, CAPAs, change controls, and audit activities.
• Demonstrated experience driving continuous improvement, risk management, or lean manufacturing initiatives.
• Strong knowledge of pharmaceutical or biopharmaceutical manufacturing processes and quality systems.
• American Society of Quality (ASQ) certification preferred.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9.