Manager, Supplier Quality

Position Overview

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 emerging biotech with the global expertise and resources of a leading oncology innovator. The mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.

The Manager for Supplier Quality will be responsible for ensuring that supplier activities comply with Rayze Bio policies, standards, procedures and global cGMPs to support commercial and clinical operations. The role provides 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 material 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 driven to completion using change management programs.
• Supports the external supplier audit program as a team member and/or lead auditor.
• Ensures that suppliers have quality and production systems that 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 Standard Operating Procedures (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 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 and applies appropriate notification to management.
• Leads teams and cross‑functional project teams to drive performance and results.
• Contributes highly to departmental performance and quality initiatives, conceptualizing the impact of quality initiatives in cross‑functional teams.
• Applies AI to improve team execution and decision‑making.
• Other QA specific responsibilities as assigned by QA management.

• Minimum bachelor’s degree in engineering or a life/physical science field (e.g., biology, biochemistry, chemistry).
• Minimum 5 years of work experience in Quality Assurance.
• Experience managing the quality of suppliers providing raw materials, consumables and services for finished product manufacturing.
• Experience with material lifecycle management.
• Familiarity with Quality Risk Management principles.
• Familiarity with SAP.
• Knowledge of US, EU and rest‑of‑world cGMP regulations and guidance.
• Demonstrated leadership, interpersonal, communication and motivation skills.
• Excellent written and oral communication skills.
• Experience requiring a high degree of attention to detail.
• Proficiency in exercising sound judgment in decision‑making.
• Demonstrated prioritization and organizational skills.

The…