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 assigned to support business needs and provide developmental opportunities.  These could include, but not limited to, participating in cross-functional team meetings to resolve non-conformance and CAPA issues and performing activities related to change controls and CAPAs.  

Education & Experience

• Bachelor’s Degree in life sciences or engineering discipline required
• 7+ years of experience in a GMP-regulated Biologics or Pharmaceutical environment required
• Extensive knowledge and experience in clinical and commercial regulations and guidance
  documents, including 21 CFR 210/211, 1271, 810 and 2001/83/EC, 2006/17/EC, 2006/86/EC, ISO, ICH, and PIC/S required
• Experience in preparing for regulatory authority inspections, including direct interaction with inspectors preferred
• Relevant industry Pharmaceutical, Biotechnology Manufacturing, and Quality operations
  experience required
• Experience in a clinical and/or commercial phase pharmaceutical environment preferred
• Experience with Contract Manufacturing Organizations preferred
• American Society of Quality Certified Quality Auditor (CQA) preferred

Knowledge, Skills, & Abilities

• Ability to prepare written communications with clarity and accuracy
• Ability to critically review responses and partner on corrective actions/commitments consistent with quality and regulatory compliance expectations
• Demonstrated ability to interface with senior leaders and cross-functional teams
• Able to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills with a strong sense of personal accountability for work tasks
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented;
  while managing multiple projects simultaneously
• Able to respond to challenges and additional projects in an understanding, positive, and
  objective manner; adaptable to dynamic conditions and project timelines
• Proficiency in Microsoft Office (Excel, Word, OneNote, PowerPoint, Visio, SharePoint) and Adobe Professional software
• Perform work that consistently requires independent decision-making and the exercise of independent judgment and discretion 

Working Environment / Physical Environment

• This position is a hybrid work schedule, minimum three days in office per week.
• Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval
• Flexibility in working schedule, i.e., off hours, second shift and weekend work as required
• Travel up to 10%
• Ability to sit at a computer terminal for an extended period of time
• Must be able to gown and gain entry into manufacturing areas
• This position is exposed to a laboratory environment

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$122,000 (entry-level qualifications) to $134,200 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day •  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.