Validation Manager, Quality Assurance

Lead QA approval and oversight of qualification/validation activities for GMP radiopharmaceutical manufacturing equipment and facilities, including radiochemistry synthesis modules, hot cells and shielding systems, automated dispensing/filling systems, sterile processing equipment, HEPA/ventilation, HVAC, and radiation containment. Oversee qualification of QC laboratory equipment and analytical instruments (radio-HPLC, GC, gamma spectroscopy, dose calibrators, microbiological systems, balances) and ensure testing (IQ/OQ/PQ) is risk-based and compliant with GxP and radiation-safety guidelines. Manage CSV for computerized/automated systems (HPLC/GC software, LIMS, EMS, MES, synthesis/automation software, asset management). Provide QA oversight during facility design, commissioning, FAT/SAT, and GMP readiness for a new radioligand manufacturing facility; review/approve qualification plans, protocols, and reports; support regulatory inspections; collaborate cross-functionally with MSET, Manufacturing, QC, and RLT operations; develop training programs and best practices for validation activities; essential leadership and organizational capabilities; role is hybrid with 4 days onsite at Watertown, MA.