Senior Specialist, Supplier Quality Management

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.

Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

The Senior Specialist, Supplier Quality Management (SQM) is responsible for supporting all aspects governing supplier quality management for ImmunityBio. This position provides support of Supplier Quality Management programs during audits and inspections and interacts cross-functionally across the ImmunityBio organization.  
 

Essential Functions

• Provides support for the implementation of the Supplier Quality Management (SQM) programs, system, and tools in the development and/or creation of procedures, work instructions, education and training materials, etc. 
• Participates on electronic system validation projects, establishment and/or review of electronic system validation documentation and performance of verification/validation/qualification testing related to system changes as needed. 
• Maintains and supports the administration of the following SQM programs: 
  • Supplier Notifications: Manages intake of supplier notifications. Coordinates cross functional ImmunityBio assessments for all notifications, as required 
  • Supplier Qualification/Decommissioning: Recommends approval or disapproval of suppliers based on compliance assessment; Partners with Procurement and Material Qualification leads to provide sourcing documentation and sourcing risk assessments 
  • Supplier Corrective Action Requests: Issues Supplier Complaints and Supplier Corrective Action Report (SCARs) in conjunction with pertinent ImmunityBio stakeholders 
  • Supplier Monitoring: Prepare/present metrics, as required.  Provides and may execute suggested remediation activities. 
  • External Audits: Performs and/or coordinates supplier and service provider audits  by developing audit plans, conducting quality audits, preparing audit reports and communicating findings, including compliance risk to support Supply Chain/ Manufacturing/Material Management/ Material Qualification/ Quality Control at ImmunityBio sites; Review and evaluate supplier’s audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet specifications and quality requirements; Follow-up on prior audit recommendations to ensure implementation and compliance 
  • Quality agreements / Change Notification Agreements: Facilitates Quality Agreement process specific to CMOs, CTOs, CROs, Materials, and Components in coordination with Subject Matter Expert owners.  Establishes Supplier Change Notification agreements for material/component suppliers operating without Quality Agreements,  
• Identifies opportunities and provides leadership for continuous improvement initiatives for ImmunityBio related to SQM programs, which may include seeking feedback from stakeholders. 
• Supports cross-functional stakeholders across the global ImmunityBio organization by consulting and providing guidance on supplier topics. 
• Maintains and completes Quality Systems records and Quality Documentation Records in a timely manner, as assigned.  
• Performs ad-hoc and cross-functional duties and/or projects as