Director of Quality — Radiopharmaceutical CDMO Leader

NorthStar; Beloit, Northern (WI, KY); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) match

Bonus plan

Equity incentive program

Paid holidays and PTO

Job summary

NorthStar Medical Radioisotopes is seeking a Director of Quality to lead all quality activities for radiopharmaceutical products in a fast-growing CDMO. You will design and scale quality systems, SOPs, and CAPAs while ensuring regulatory compliance and audit readiness.

Ideal candidates have a minimum of ten years in quality within cGMP pharma/radiopharma and at least five years in leadership, with preferred exposure to radiopharmaceuticals and ISPE/ASQ standards.

Qualifications

• Bachelor’s degree and minimum ten years of Quality experience in a cGMP pharmaceutical, biotech, or radiopharmaceutical manufacturing.
• Minimum of five years in management or leadership roles.
• Experience with radiopharmaceuticals, nuclear medicine, or radioactive materials testing preferred.

Responsibilities

• Lead and oversee all quality activities supporting manufacture, testing, release, and stability of radiopharmaceutical products in a cGMP environment.
• Design, implement, and elevate quality systems, SOPs, and workflows for a growing CDMO.
• Lead investigations, deviations, OOS/OOT, and CAPA processes with timely root-cause analysis.
• Drive audits, inspections, and inspection readiness with disciplined documentation and training.
• Mentor and grow the quality team, fostering a collaborative, quality-first culture.
• Contribute to QA, QC, Validation strategies and technology transfer activities.

Skills

Quality systems

SOP development

Laboratory equipment

cGMP compliance

Regulatory compliance

Audits & inspections

Data integrity

Team leadership

Radiopharmaceuticals

Education

Bachelor’s degree in Microbiology/Biochemistry/Chemistry/Pharmaceutical Sciences

ASQ certification (preferred)

Tools

Laboratory instrumentation

Job description

NorthStar Medical Radioisotopes is seeking a Director of Quality to lead all quality activities for radiopharmaceutical products in a fast-growing CDMO. You will design and scale quality systems, SOPs, and CAPAs while ensuring regulatory compliance and audit readiness.

Ideal candidates have a minimum of ten years in quality within cGMP pharma/radiopharma and at least five years in leadership, with preferred exposure to radiopharmaceuticals and ISPE/ASQ standards.