SeniorSpecialist,QualityOperations

**Job Title: Senior Specialist, Quality Operations** **Location: Hamilton, Ontario** **Onsite 5 days/week** Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radio conjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant, brand new radio conjugate manufacturing facility to meet the demand for our growing pipeline of RCs. **Position Summary** The Senior Specialist, Quality Operations ensures day-to-day quality oversight of manufacturing, packaging, testing, and distribution activities. The role executes quality system processes, provides on-the-floor support, and drives robust investigations and CAPA to protect product quality, patient safety, and regulatory compliance. This position partners closely with Operations, QC, Supply Chain, Engineering, and Regulatory to maintain right-first-time execution and continuous improvement. This position reports to AD, Quality Operations. **Key Responsibilities** * Provide on-the-floor QA presence for manufacturing and packaging; verify adherence to procedures, critical parameters, and line clearance; support start-up, interventions, and batch record execution. * Lead or facilitate timely investigations using root cause tools (5-Why, Ishikawa, FMEA); define corrective/preventive actions; perform effectiveness checks; trend issues and drive systemic fixes. * Author, assess, and approve changes to processes, equipment, materials, and documentation; ensure risk assessments and validation impacts are addressed. * Operate QMS elements including SOPs, training, complaints, supplier quality, stability, APR/PQR inputs, an