Manager, Supplier Quality

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.

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 RayzeBio 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 Operation 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 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.

Education And Experience

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.