Manager, Supplier Quality

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly‑owned subsidiary of Bristol Myers Squibb, Rayze Bio 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 Rayze Bio:

The Manager for Supplier Quality will be responsible for ensuring supplier activities are in compliance with Rayze Bio 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.

• Oversees the qualification and management of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) vendors, including 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.
• Manages the lifecycle of materials used for the manufacture of starting materials, drug substance, and drug products, involving qualification, maintenance, and reduced testing.
• Provides oversight and review of supplier complaints and responses.
• Conducts quality assessment of supplier change notifications and ensures actions are completed via change management programs.
• Supports the external supplier audit program as a team member or lead auditor, ensuring suppliers meet applicable regulatory, cGMP and Rayze Bio requirements. Evaluates observation responses, tracks responses and follows up actions to closure.
• Handles discrepancy reporting, deviations and Corrective and Preventive Actions (CAPA) related to nonconforming materials or services provided by vendors.
• Performs quality reviews and approvals for functional area documents, including SOPs, technical documents, reports, agreements, qualifications, and various forms.
• Establishes and implements processes to ensure quality oversight of on‑site service vendors, collaborating closely with Facilities & Engineering, MS&T, and QA Operations.
• Coordinates and leads meetings with site stakeholders, other network sites, and external partners to execute vendor and material management programs, including discussions, negotiations, and dispute resolution.
• Leads the team in cross‑functional meetings and initiatives concerning supplier and material activities.
• Participates as a core team member in any corporate or health authority inspections.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies, applying appropriate notification to management as needed.
• Leads teams and cross‑functional project teams, driving team performance and results. Contributes heavily to departmental performance and quality initiatives; conceptualizes impact of quality initiatives in terms of cross‑functional teams.
• Applies AI to improve team execution and decision‑making.
• Other QA specific responsibilities as assigned by QA management.

• At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.
• Minimum 5 years of work experience in Quality Assurance.
• Experience in managing the quality of suppliers providing raw materials, consumables and services for finished product manufacturing is highly preferred. Experience with material lifecycle management is highly preferred. Familiarity with Quality Risk Management principles is valuable.
• Familiarity with SAP is valuable.
• Knowledge of US, EU and rest‑of‑world cGMP…