Director, Quality

Overview

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, North Star Medical Radioisotopes is the place to do it. North Star 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 North Star’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.

The Director, Quality is responsible for leading and overseeing all quality activities supporting the manufacture, testing, release, and stability of radiopharmaceutical drug products and APIs within a cGMP-regulated environment. This role provides both strategic and hands-on leadership to build, operate, and continuously improve the Quality unit in a fast-growing CDMO organization. The position ensures quality control, quality assurance, validation, regulatory, and training activities are compliant, efficient, and aligned with rapid development timelines and lean manufacturing principles, while supporting the development of team capabilities and scaling of North Star’s systems, processes, and culture.

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 radio chemical 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…