Manager, Supplier Quality

About the role

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.

Job 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.
• Handle discrepancy reporting, deviations and Corrective and Preventive Actions (CAPA) related to nonconforming materials or services provided by vendors.
• Perform quality reviews and approvals for functional area documents, including Standard Operation Procedures (SOPs), technical documents, reports, agreements, qualifications, and various forms.
• Establishes 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 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 and applies appropriate notification to management as appropriate.
• Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams.
• Applies AI to improve team execution and decision-making.

Qualifications

• 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, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.