Associate Director, Clinical, Preclinical and Diagnostic QA

Associate Director, Clinical, Pre-Clinical & Diagnostic QA

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.

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 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

Knowledge, Skills, & Abilities

Working Environment / Physical 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.

National Market

$170,000 (entry-level qualifications) to $188,000 (highly experienced) annually

Premium Market

$176,000 (entry-level qualifications) to $195,000 (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.