Executive Director, Head of Quality

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RayzeBio is an innovative biotechnology company based in San Diego, CA, and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary. Since its inception in late 2020, RayzeBio has been dedicated to improving the survival of cancer patients through targeted radioisotopes. As a standalone entity within BMS, RayzeBio is poised to lead the charge in radiopharmaceuticals, leveraging BMS’s world-class oncology expertise. RayzeBio’s lead asset, RYZ101, is currently in Phase 3 testing for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and advancing in early-stage clinical trials for small cell lung cancer (SCLC) and breast cancer.   Additionally, RayzeBio is developing a broad pipeline of early drug candidates into early human clinical trials.

RayzeBio is committed to becoming the global leader in radiopharmaceuticals, and this journey requires a seasoned, visionary leader to direct quality operations and ensure world-class compliance and readiness for regulatory inspections.

Summary

RayzeBio seeks an experienced Executive Director, Head of Quality to lead and strategically oversee the entire Quality function at our state-of-the-art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN. In this pivotal executive role, you will provide leadership and guidance across Quality Assurance, Quality Systems, Quality Control, and Clinical Quality while ensuring GMP and GCP compliance, operational excellence, and readiness for global regulatory inspections, including the FDA’s Pre-Approval Inspection (PAI). Additionally, you will oversee and drive the design, implementation, and continuous improvement of quality systems, ensuring that the highest standards are maintained as we prepare for the commercialization of radiopharmaceutical products.

As a key RayzeBio Manufacturing and Clinical Leadership Team member, you will collaborate closely with senior executives across RayzeBio and Bristol Myers Squibb, driving the vision and execution of quality initiatives that support the safe, effective, and compliant delivery of life-saving therapies. This role reports to the Chief, Product Development and Operations, and is based in Indianapolis, IN.

Key Responsibilities

• Lead Quality Operations:

  • Oversee the entire Quality function at the Radiopharmaceutical Manufacturing Facility and External GMP partners ensuring strict adherence to GMP regulations, company policies, and global regulatory requirements (FDA, EMA, PMDA, etc.).

  • Oversee the Quality function responsible for GCP oversight of the Clinical Studies ensuring strict adherence to GCP Regulations, company policies, and global regulatory requirements.

• Prepare for Regulatory Inspections: Lead and manage the site’s preparation for critical inspections, including Pre-Approval Inspections (PAIs) by the FDA and other regulatory agencies, ensuring readiness and flawless execution.

• Operational Excellence and Continuous Improvement: Drive operational excellence across the Quality organization, optimizing processes for product quality, GMP and GCP compliance, supply chain efficiency, and regulatory adherence.

• Develop and Lead Quality Teams: Build and inspire high-performing teams across Quality Assurance, Quality Systems, and Quality Control. Foster talent development, mentorship, and a culture of continuous improvement.

• Cross-Functional Leadership: Partner with leaders from Facilities & Engineering, Manufacturing, Clinical Operations, MS&T, and IT to ensure alignment in the preparation for commercial-scale operations and regula