Director, Quality

NorthStar Medical Technologies; Beloit (WI); On-site; USD 180,000 - 280,000; Full time

Job summary

NorthStar Medical Radioisotopes seeks a senior quality leader to build and scale its cGMP quality systems for radiopharmaceutical manufacturing. You will oversee QA strategy, investigations, and inspections to ensure compliance and product integrity.

With a decade of quality experience in pharma or radiopharma and at least five years in management, you will mentor a growing team, drive data integrity, and partner across CDMO functions to enable fast, compliant development and release.

Qualifications

• Minimum ten years of Quality experience in a cGMP pharmaceutical, biotech, or radiopharmaceutical manufacturing.
• Five+ years of management experience or equivalent.
• Experience in small companies/startups with hands-on approach.

Responsibilities

• Design, implement, and evolve quality systems, processes, procedures, and workflows for a growing CDMO.
• Lead development and maintenance of SOPs, specifications, and templates.
• Support selection and lifecycle management of laboratory equipment, software and analytical tools.
• Lead investigations of deviations, OOS/OOT results, and CAPAs; drive root cause analysis.
• Maintain inspection readiness and participate in audits and inspections.
• Mentor and manage a growing quality team; train analysts on cGMP and data integrity.
• Contribute to QA, QC, and Validation strategies aligned with company growth.

Skills

Quality leadership

cGMP compliance

Data integrity

Regulatory knowledge

Education

Bachelor's Degree in Microbiology/ Biochemistry/ Chemistry/ Pharmaceutical Sciences

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.

Building & Scaling Quality in an Innovating Environment

• Help design, implement, and evolve quality systems, processes, procedures, and workflows suitable for an emerging and growing CDMO operation.
• Lead the development, authorship, and maintenance of SOPs, specifications, and templates with a “right sized” startup mindset.
• Support selection, qualification, and lifecycle management of laboratory equipment, software and analytical tools.
• Partner with Business Development, Facilities, Manufacturing, Engineering, and Analytical Development to identify gaps and implement practical solutions quickly.

cGMP Compliance & Quality Systems

• Ensure all activities comply with applicable cGMP requirements (FDA 21 CFR Parts 11, 210 and 211), data integrity expectations, and global regulatory standards.
• Lead or support investigations related to deviations, OOS/OOT results, and atypical events, driving timely and effective root cause analysis and CAPAs.
• Actively participate in audits and inspections, including facility readiness, inspection hosting, and response development.
• Maintain strong inspection readiness through disciplined documentation, training, and laboratory practices.

Analytical Methods & Technical Support

• Support method validation, verification, qualification, and transfer for radiopharmaceutical specific test methods, including radiochemical purity, identity, and sterility/endotoxin testing.
• Work closely with Analytical Development to transition early phase methods into routine QC use.
• Provide technical troubleshooting support for analytical methods, equipment issues, and data anomalies.

Continuous Improvement & Strategy

• Drive continuous improvement initiatives focused on efficiency, compliance, automation, and right-first-time execution.
• Contribute to QA strategy, including integrated software, process flows, and data integrity/scalability aligned with company growth.
• Contribute to QC strategy, including laboratory expansion, equipment qualification, and capability building aligned with company growth.
• Contribute to Validation strategy, including life cycle management, in-house capabilities, and scalable phase appropriate actions aligned with company growth.
• Monitor industry trends, regulatory updates, and emerging technologies relevant to radiopharmaceutical quality.

CDMO & Client Engagement

• Support quality aspects of CDMO programs, including client onboarding, quality agreements, knowledge transfer, technical discussions, and program execution.
• Support project management team, addressing testing approaches, timelines, deviations, and data questions.
• Support technology transfer activities from client or internal development programs into manufacturing and QC operations.
• Directly manage and mentor a growing quality team, leading by example in both technical execution and quality mindset.
• Train and coach analysts on cGMP expectations, data integrity, and phase appropriate processes.
• Foster a collaborative, problem solving culture well suited for an emerging company.

Bachelor’s Degree in a Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, or related scientific discipline and minimum ten (10) years of Quality experience in a cGMP pharmaceutical, biotech, or radiopharmaceutical manufacturing with a minimum of five (5) years of management experience; or equivalent combination of education and experience.

Additional required experience includes:

• Demonstrated experience working in small companies or startup environments, with a willingness to be hands on.
• Experience with radiopharmaceuticals, nuclear medicine, or radioactive materials testing strongly preferred.

Experience supporting manufacturing operations with tight timelines and rapid release requirements.

Knowledge of International Society for Pharmaceutical Engineering (ISPE) standards preferred, as well as advanced degree and American Society of Quality (ASQ) certification.

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.