ImmunityBio

Senior Specialist, Quality Risk Management

El Segundo, CA · Senior

Sponsorship not specifiedDetected 30 days ago

ComplianceExcelProcess ImprovementGMPLeadershipCommunicationProblem SolvingMentoringAdaptabilityMicrosoft OfficeSharePointHACCP

About the role

The Senior Specialist, Quality Risk Management is responsible for supporting all aspects governing Quality Risk Management for ImmunityBio.
This position interacts cross-functionally across the ImmunityBio organization.
Tracks QRM program records and deliverables.

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.
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.
Provides guidance on risk mitigation strategies and support decision‑making for deviations, CAPAs, change controls, and investigations.
Provides support and participates as the Subject Matter Expert for the QRM program during audits and inspections.
Delivers training and coaching on QRM principles, tools, and best practices.
Partners with IB stakeholders to embed risk-based approaches to daily operations and strategic initiatives.
Supports leading and facilitating risk assessments as requested by stakeholders.
Maintains and completes Quality Systems records and Quality Documentation Records in a timely manner, as assigned.

Prepares and presents data and reports as well as meeting minutes associated with QRM metrics, as required.
Bachelor's Degree in a life sciences or engineering discipline with a minimum of 7+ years of experience in a GMP-regulated Biologics or Pharmaceutical environment required.
5+ years' 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.
Must have strong authorship and be able 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.
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.

Experience in preparing for regulatory authority inspections, including direct interaction with inspectors preferred.
Experience in a clinical and/or commercial phase pharmaceutical environment preferred.
American Society of Quality Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt Certification preferred.

Supports the implementation of the Quality Risk Management (QRM) program, system, and tools through the development and/or creation of procedures, work instructions, education and training materials, etc.

Ability 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.

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

This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.