Senior Specialist, Supplier Quality Management

ImmunityBio•Culver City, CA

3d•Hybrid

About The Position

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.

Requirements

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
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

Responsibilities

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.

Benefits

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