What are the responsibilities and job description for the Director, Supplier Quality position at Fusion Pharmaceuticals US, Inc.?
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes : FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
Summary of the position
The Director of Supplier Quality is responsible for overseeing the quality assurance processes related to suppliers and ensuring that all products meet the company's quality standards. This role involves developing supplier quality strategies, conducting audits, managing supplier relationships, and collaborating with cross-functional teams to drive continuous improvement initiatives. This role will partner closely with business stakeholders to ensure identification and mitigation of risks, alignment with regulatory and commercial strategy and continuing support of Fusion's clinical development pipeline. The Director, Supplier Quality will report directly to the Vice President, Quality.
Responsibilities
- Develop and implement a comprehensive supplier quality strategy aligned with organizational goals
- Evaluate and select suppliers based on quality performance, capabilities, and risk assessments
- Establish and maintain strong relationships with key suppliers to drive quality improvements
- Oversee supplier audits and assessments, ensuring adherence to quality standards and regulations.
- Develop and implement quality metrics to monitor supplier performance.
- Collaborate with suppliers and internal teams to identify areas for quality improvement.
- Drive initiatives such as root cause analysis and corrective action plans for quality issues.
- Work closely with procurement, engineering, and manufacturing teams to align supplier quality goals with operational needs.
- Facilitate training and knowledge sharing regarding quality standards and processes.
- Prepare quality reports for senior management, highlighting trends and areas of concern.
Qualifications
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.