Hybrid Senior QA Lead — Radioligand Therapy Manufacturing

Mariana Oncology; Watertown (MA); Hybrid; USD 85,400 - 158,600; Full time

Job summary

Mariana Oncology in Watertown, MA is seeking an experienced Senior Manager, QA, RLT Manufacturing Operations to lead the QA RLT Operations team and ensure radiopharmaceutical products are manufactured, tested, and released in full compliance with cGMP, radiation safety, and global quality standards.

This hybrid role requires collaboration with manufacturing, QC, manufacturing sciences & technology, and radiological safety teams to maintain inspection readiness and drive continuous improvement in

Qualifications

• Bachelor’s or Master’s degree in a scientific or engineering field with at least ten years in QA for pharma/biotech.
• Experience with radiopharmaceuticals and oncology is a plus.
• Experience implementing global QMS aligned with EU GMP and 21 CFR 11.
• Ability to collaborate with manufacturing, QC, supply chain, and facilities.
• Commitment to data integrity and compliance.

Responsibilities

• Provide QA oversight to daily RLT GMP operations and batch release.
• Review deviations, CAPAs, change controls, and quality investigations.
• Lead training and development for the QA RLT Operations team.
• Ensure inspection readiness for internal audits and regulatory inspections.
• Support technology transfer and lifecycle maintenance of products.

Skills

Cross-functional collaboration

Data integrity

GMP compliance

QA in pharma

cGMP knowledge

Education

Bachelor’s or Master’s degree in scientific or engineering field

Job description

Mariana Oncology in Watertown, MA is seeking an experienced Senior Manager, QA, RLT Manufacturing Operations to lead the QA RLT Operations team and ensure radiopharmaceutical products are manufactured, tested, and released in full compliance with cGMP, radiation safety, and global quality standards.

This hybrid role requires collaboration with manufacturing, QC, manufacturing sciences & technology, and radiological safety teams to maintain inspection readiness and drive continuous improvement in