Radiopharmaceutical QA Lead - Compliance & Release

Mariana Oncology, Inc.; Northern (KY); Hybrid; USD 85,000 - 159,000; Full time

Job summary

Mariana Oncology, Inc. is seeking an experienced Associate Director, Quality Assurance to join our Quality Assurance organization in a hybrid role at the Watertown manufacturing facility.

The Senior QA Specialist role ensures radiopharmaceutical products are manufactured, tested, and released in full cGMP compliance and under radiation safety regulations. You will oversee daily operations, support batch review and release, manage deviations and CAPAs, and partner with manufacturing, QC, and

Qualifications

• Bachelor’s or Master’s degree in a relevant science or engineering field with 10+ years QA experience.
• Experience with radiopharmaceuticals and oncology is a plus.
• Knowledge of EU GMP Vol 4 Part I, IV and EU Annexes, 21 CFR 210–212, 21 CFR 11, ICH, and USP requirements.
• Experience in aseptic operations, isotopes/radioligands, or PET/SPECT environments preferred.

Responsibilities

• Lead QA RLT Operations team and train staff.
• Provide QA oversight for radioligand manufacturing and aseptic processing.
• Review batch records, specs, and release decisions.
• Manage deviations, CAPAs, change controls, and investigations.
• Support audits and regulatory inspections.

Skills

GMP compliance

QA oversight

Data integrity

Cross-functional teamwork

Radiopharma experience

Education

Bachelor’s or Master’s degree in science/engineering

Tools

QMS software

Regulatory knowledge (FDA/EMA)

Job description

Mariana Oncology, Inc. is seeking an experienced Associate Director, Quality Assurance to join our Quality Assurance organization in a hybrid role at the Watertown manufacturing facility.

The Senior QA Specialist role ensures radiopharmaceutical products are manufactured, tested, and released in full cGMP compliance and under radiation safety regulations. You will oversee daily operations, support batch review and release, manage deviations and CAPAs, and partner with manufacturing, QC, and