Manager, Supplier Quality

About the role

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ The Manager for Supplier Quality will be responsible for ensuring supplier activities are in compliance with RayzeBio policies, standards, procedures and global cGMPs to support commercial and clinical operations. In addition, the role will provide leadership of material lifecycle management, qualification, change management, non-conformance, and continuous improvement.

Responsibilities

• Oversees the qualification and management of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) vendors. This includes identifying and assessing new vendors, developing and revising Quality Agreements, and maintaining the Approved Vendor List.
• Manages site implementation of material qualification, vendor change notification, and material non-conformance programs.
• Manage the lifecycle of materials used for the manufacture of starting materials, drug substance, and drug products, which involves material qualification, maintenance, and reduced testing.
• Provides oversight and review of supplier complaints and responses
• Conduct quality assessment of supplier change notifications and ensure actions are driven to completion utilizing change management programs.
• Support the external supplier audit program as a team member and/or lead auditor.
• Ensure that suppliers have quality and production systems that meet applicable regulatory, cGMP and RayzeBio requirements.
• Evaluate observation responses, track responses and follow up actions to closure.