Associate Director, Clinical, Preclinical and Diagnostic QA

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 Associate Director, Clinical, Pre-Clinical & Diagnostic QA will play a key role in Quality Assurance and have direct responsibility for the clinical quality workstreams and study teams. This role is responsible for providing quality and compliance oversight for ImmunityBio sponsored clinical trials with respect to IBRX SOPs, Standards, and applicable regulatory requirements (i.e. ICH and US FDA regulations, DGCI, SAHPRA, MHRA, EMA) The Associate Director manages the development, implementation, maintenance, and quality oversight for clinical trial audit and inspection, quality risk management and quality improvement programs, and is an active auditing role. This role may also have direct oversight and training of Preclinical and Quality Systems personnel within Development Quality Assurance.

Essential Functions

• Partner with Quality Leadership to develop a risk-based GCP audit program and compliance strategy for IBRX clinical studies.
• Ensure readiness for external audits and inspections and comply with ImmunityBio clinical quality standards. Support regulatory inspections (FDA/EMA/MHRA/PMDA/Health Canada) including assistance with inspection readiness and post-inspection activities.
• Lead, manage, and train cross-functionally within Development Quality Assurance. Oversee the performance of designated staff inclusive of planning, assigning and directing the work of direct reports as well as hiring new team members, coaching and training junior team members to become auditors as needed.
• Lead and train teams, develop program plans and systems, actively audit and manage program performance to goals, and report results to management.
• Assist in the investigation and resolution of clinical trial non-conformances and ensure that appropriate and timely corrective and preventive actions are implemented and documented. 
• Develop, monitor, and report status of compliance metrics including KPIs identifying adverse trends and potential risk for the organization.
• Act as Lead and SME in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
• Build the QMS for Clinical and Preclinical QA with a focus on GCP and GLP regulations and guidance.
• Draft, revise, contribute and adhere to the development and review of Standard Operating Procedures (SOPs) and other controlled documents (forms, templates, work instructions)
• Oversee the supplier audit program and the deviations/nonconformance process.
• Performs other special projects and/or duties as assigned.

Education & Experience

• Bachelor’s degree in a life sciences or engineering discipline with 8+ years of progressive experience in a GCP-regulated Biotech or Pharmaceutical Sponsor environment required; or
• Master’s degree in a life sciences or engineering discipline with 6+ years of progressive experience in a GCP-regulated Biotech or Pharmaceutical Sponsor environment required; or
• Experience in 21 CFR -- Part 312, Part 50, Part 54, Part 56, Part 58 [if applicable], Part 314, Part 11 and other applicable regulations required.
• Experience in inspection readiness activities and regulatory hosting required
• Experience hiring, training, and leading cross-functional teams required
• Experience in Early