Senior QA Lead, Radiopharmaceutical Ops (Hybrid)

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

Job summary

Mariana Oncology, Inc. in Watertown, MA is seeking a Senior QA Specialist to join the Quality Assurance organization, ensuring radiopharmaceuticals are manufactured, tested, and released in full cGMP compliance.

You will provide QA oversight to daily operations, support batch review and release, and collaborate with manufacturing, QC, and radiological safety teams in a fast-paced, regulated environment. The role emphasizes leadership, training, and continuous improvement in radioligand

Qualifications

• Bachelor’s or Master’s degree in relevant scientific or engineering discipline with at least ten years of experience working within Quality Assurance in the pharmaceutical or biotechnology industry.
• Experience working with radiopharmaceuticals and/or oncology will be considered as a plus.
• Experience with a global QMS adhering to EU GMP Vol 4 Part I, IV, and applicable EU GMP Annexes (incl. Annex 1/3), 21 CFR 210-212, 21 CFR Part 11, ICH, and USP.
• Experience supporting aseptic operations, isotopes/radioligands, or PET/SPECT radiopharmaceutical environments preferred.
• Ability to work collaboratively with cross functional teams including manufacturing, quality control, supply chain, technical development, and facilities personnel.

Responsibilities

• Lead and coach QA RLT Operations team to foster quality and compliance.
• Provide SME guidance on radiopharmaceutical GMP requirements and radiation-handling quality.
• Review batch records, specifications, and reports for radiopharmaceutical products.
• Manage deviations, CAPAs, change controls, and risk assessments.
• Support regulatory inspections and maintain data integrity across operations.

Skills

QA leadership

Regulatory compliance

Radiopharmaceuticals

cGMP

Data integrity

Education

Bachelor’s/Master’s in science or engineering

Job description

Mariana Oncology, Inc. in Watertown, MA is seeking a Senior QA Specialist to join the Quality Assurance organization, ensuring radiopharmaceuticals are manufactured, tested, and released in full cGMP compliance.

You will provide QA oversight to daily operations, support batch review and release, and collaborate with manufacturing, QC, and radiological safety teams in a fast-paced, regulated environment. The role emphasizes leadership, training, and continuous improvement in radioligand