Manager, Supplier Quality

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 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 https //

• 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. 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.
• Manage the lifecycle of materials used for the manufacture of starting materials, drug substance, and drug products, including 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 using 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 Rayze Bio requirements. Evaluate observation responses, track responses and follow up actions to closure.
• Handle discrepancy reporting, deviations and CAPA related to nonconforming materials or services provided by vendors.
• Perform quality reviews and approvals for functional area documents, including SOPs, technical documents, reports, agreements, qualifications, and various forms.
• Establish and implement processes to ensure quality oversight of on-site service vendors, collaborating closely with Facilities & Engineering, MS&T, and QA Operations.
• Coordinate and lead meetings with site stakeholders, other network sites, and external partners to execute vendor and material management programs, including discussions, negotiations, and dispute resolution.
• Lead 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 as appropriate.
• Leads teams and cross-functional project teams and drives team performance and results. Contributes to departmental performance and quality initiatives; capable of conceptualizing cross-functional impact of Quality initiatives.
• 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 regulations and guidance.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility requiring a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a laboratory environment; protective clothing, gloves, and safety glasses are required when working with radioactive materials.

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