Strategic Supplier Quality Manager (GMP/GDP)

Bristol Myers Squibb; United States; Remote; USD 124,000 - 151,000; Full time

Benefits offered by this job

Flexible Time Off

Stock opportunities

Discretionary incentive cash

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is hiring a Manager for Supplier Quality to ensure supplier activities align with RayzeBio policies and global cGMPs, supporting commercial and clinical operations. Lead material qualification, change management, non-conformance, and continuous improvement with cross-functional teams.

The role requires a bachelor’s degree in engineering or life/physical sciences and at least 5 years in QA, with SAP familiarity and knowledge of US/EU

Qualifications

• At minimum, a bachelor's degree in engineering or a life or physical science related field 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.
• 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.

Responsibilities

• Oversees the qualification and management of GMP and GDP vendors and maintains the Approved Vendor List.
• Manages site implementation of material qualification, vendor change notifications, and material non-conformance programs.
• Manage the lifecycle of materials used for manufacture of starting materials, drug substance, and drug products.
• Provides oversight and review of supplier complaints and responses.
• Conduct quality assessment of supplier change notifications and ensure actions are driven to completion.
• Support the external supplier audit program as a team member or lead auditor.
• Ensure suppliers have quality and production systems meeting regulatory, cGMP and RayzeBio requirements.
• Evaluate observation responses and track closure actions.
• Handle discrepancy reporting, deviations and CAPA related to nonconforming materials or services.
• Perform quality reviews and approvals for SOPs, technical documents, reports and agreements.
• Establish and implement processes to ensure quality oversight of on-site service vendors.
• Coordinate and lead meetings with stakeholders to execute vendor and material management programs.
• Lead cross-functional project teams and drive performance and results.
• Participate as a core team member in corporate or health authority inspections.
• Identify and report discrepancies from required work practices to management.
• Apply AI to improve team execution and decision-making.

Skills

Quality Assurance

Leadership

Regulatory knowledge

Attention to detail

Communication skills

Education

Bachelor's degree in engineering or life/physical science

Tools

SAP

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is hiring a Manager for Supplier Quality to ensure supplier activities align with RayzeBio policies and global cGMPs, supporting commercial and clinical operations. Lead material qualification, change management, non-conformance, and continuous improvement with cross-functional teams.

The role requires a bachelor’s degree in engineering or life/physical sciences and at least 5 years in QA, with SAP familiarity and knowledge of US/EU