Site Quality Director

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About the role

Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radioconjugates that deliver powerful alpha‑emitting payloads directly to tumors. Our pipeline spans multiple first‑in‑class programs—backed by a GMP‑compliant, state‑of‑the‑art radiopharmaceutical facility in Hamilton, we’re turning cutting‑edge science into real‑world impact for patients. Join us at the forefront of radiopharma innovation and be part of turning breakthrough science into meaningful outcomes for patients—come build what’s next with us! Note: This role is 5 days per week onsite. Position Summary: Provide strong site leadership and oversight to ensure responsibilities regarding QA, QC and site compliance activities. The position is accountable for assuring the supply of radio conjugate quality products to markets and ensuring cGMP compliance at the site. Responsible for leading, directing, identifying and setting quality goals, objectives, and perfect execution in alignment with Global Quality Goals.  Maintain cGMP compliance at site, including harmonization of procedures in alignment with Global Policies & Standards.  Ensuring the materials and products are tested and released in a timely manner by adhering to approved procedures and specifications. Acts as a champion for building a “Culture of Quality” across the organization. Accountable to assure site is always ready for all regulatory inspections.  This role will report directly to the Head of Quality, Radiopharmaceutical. Responsibilities: • Ensure all finished products intended for use in the market are safe and effective as per cGMP requirements, regulatory commitments, AZ policies & procedures and site SOPs. • Set site quality goals, objectives and strategic direction in alignment with Global Radio Conjugate Quality goals. • Track, trend, maintain and report all Quality and business metrics to monitor and action all QA & QC compliance activities. • Prevent Quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company.  Non-compliance issues are to be addressed via corrective and preventive actions (CAPA). • Ensure rationalization and management of Quality processes, operations and systems. Perform gap analysis to plan actions for continuous improvements. • Resource planning and monitoring for head count projections, manage site budget, capital budget and manage organizational development. • Responsible for site lean design and execution of continuous Quality & Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance, drive efficiencies and reduce cost of poor quality. • Coach and develop direct and indirect reports, as appropriate, through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities. • Performs all work in support of our Corporate Values and Behaviors and in accordance with established regulatory and compliance and safety requirements. • Ensure the raw material, packaging material and finished products are tested and released in accordance to approved specification and test methods in a timely manner as per the site commits and support business needs. • Ensure the health authority and Annex 1 requirements at the site are met for sterile products. • Support the development of site strategy to respond to audit observations, inspection findings and implement corrective actions. • Create and maintain 24/7 inspection readiness at the Hamilton site. • Be a solution-oriented leader and role model AZ behaviors. • This is a supervisory position with direct repo

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