Senior QA Director — Radiopharma Site Compliance

Nucleus RadioPharma; Rochester (MN); On-site; USD 190,000 - 250,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HSA/FSA eligible

401k with employer matching

Relocation assistance

Job summary

Nucleus RadioPharma is seeking a Senior Director, Quality Assurance to lead the Quality function at the Rochester, MN site. This hands-on executive oversees QA, sterility, laboratory operations, batch disposition, and inspection readiness for clinical and future commercial radiopharmaceutical manufacturing.

The role requires a strong track record in cGMP environments, FDA inspections, and cross-functional leadership to drive a culture of quality and data integrity on site.

Qualifications

• Bachelor's degree in a relevant science or engineering.
• 10+ years in quality leadership for cGMP drug manufacturing.
• Experience leading site QA, sterilization, and batch disposition.

Responsibilities

• Lead Rochester QA as site Quality decision-maker and interface with QC/Operations.
• Approve or pause manufacturing actions when patient safety or quality is at risk.
• Oversee cGMP operations, aseptic processing, radiolabeling, filling, and testing quality control.
• Own quality systems including deviations, CAPAs, change control, supplier quality, and eQMS.

Skills

Quality leadership

cGMP

FDA inspections

QA systems

Sterile manufacturing

Change control

Risk management

Cross-functional collaboration

Education

Bachelor's degree (pharmacy/chemistry/biology/engineering)

Advanced scientific degree

Tools

eQMS

Job description

Nucleus RadioPharma is seeking a Senior Director, Quality Assurance to lead the Quality function at the Rochester, MN site. This hands-on executive oversees QA, sterility, laboratory operations, batch disposition, and inspection readiness for clinical and future commercial radiopharmaceutical manufacturing.

The role requires a strong track record in cGMP environments, FDA inspections, and cross-functional leadership to drive a culture of quality and data integrity on site.