Associate Director, Quality

AstraZeneca • Boston, MA

2d • Hybrid

About The Position

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 Associate Director, 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 Supplier Quality Lead will report directly to the Vice President, Quality. This position is based out of our Boston, MA office and will follow a hybrid work schedule.

Requirements

• Bachelor’s degree in Engineering, Quality Assurance, Supply Chain Management, or a related field
• Minimum of 10-12 years of experience in supplier quality management
• Strong knowledge of quality management systems (e.g., ICHQ10) and quality tools (e.g., Six Sigma, Lean)
• Excellent analytical, problem-solving, and decision-making skills
• Strong communication and interpersonal skills, with the ability to work collaboratively across functions.
• Demonstrated ability to effectively lead professional staff and teams
• Familiarity with supplier risk management and assessment methodologies
• Proficiency in quality management software and data analysis tools
• Approximately 20-30% business travel required to external Contract Development Manufacturing Organization (CDMO) / Business Partner sites, or to attend professional development training seminars – as needed / directed

Nice To Haves

• Master’s degree preferred
• Prior experience with radiopharmaceuticals is desired
• Phase 1/Phase 2 supplier quality management experience in a Biotech/Pharma setting desired

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.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees