Talent.com
No longer accepting applications
Associate Director, Clinical, Preclinical and Diagnostic QA

Associate Director, Clinical, Preclinical and Diagnostic QA

ImmunityBioEl Segundo, CA, United States
30+ days ago
Job type
  • Full-time
Job description

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 Phase (1-2) clinical trials required, Phase 3-4 preferred
  • American Society of Quality Certified Quality Auditor (CQA) preferred.
  • Knowledge, Skills, & Abilities

  • Strong working knowledge and understanding of GCP regulations and an ability to apply them to clinical research including FDA regulations, ICH, and GCP guidelines. Able to act as a resource for colleagues.
  • Ability to effectively communicate with business partners and third-party vendors and their quality assurance representatives to ensure IBRX requirements are met and to resolve issues / discrepancies.
  • Strong oral and written presentation skills to address colleagues at all levels of the organization.
  • Ability to work on multiple projects, manage competing priorities and collaborate cross-functionally in a dynamic fast-paced environment.
  • Strong problem solving and analytical skills with demonstrated ability to be detail oriented, while managing multiple projects simultaneously
  • Working Environment / Physical Environment

  • This role may be hybrid or remote.
  • Flexibility in working schedule, i.e., off-hours, second shift and weekends as needed.
  • Must possess mobility to work in an office setting and to use standard office equipment, including a computer.
  • Must possess mobility to audit various types of suppliers, laboratories, and investigator sites - both domestic and international
  • Lift and carry materials weighing up to 20 pounds.
  • 15-20% travel may be required.
  • 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.

    Create a job alert for this search

    Associate Director Clinical • El Segundo, CA, United States

    Related jobs
    • Promoted
    Director of Antimicrobial Stewardship Clinical Position in Infectious Diseases 2025-2026

    Director of Antimicrobial Stewardship Clinical Position in Infectious Diseases 2025-2026

    University of California - Los Angeles (UCLA)Los Angeles, CA, United States
    Full-time
    Director of Antimicrobial Stewardship .The posted UC salary scales [https : / / www.The salary range for this position is $163,300-$429,000. This position includes membership in the health sciences c...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director of Antimicrobial Stewardship - UCLA West Valley 2025-2026

    Associate Director of Antimicrobial Stewardship - UCLA West Valley 2025-2026

    University of California - Los Angeles (UCLA)Los Angeles, CA, United States
    Full-time
    Associate Director of Antimicrobial Stewardship .The posted UC salary scales [https : / / www.The salary range for this position is $142,100-$429,000. This position includes membership in the health s...Show moreLast updated: 30+ days ago
    • Promoted
    Director of Head and Neck Pathology

    Director of Head and Neck Pathology

    University of California - IrvineOrange, CA, United States
    Full-time
    The university academic base salaries as to rank and step can be found here : UC Salary scales.However, for this position the total negotiated salary uses AAMC salary benchmarks for Anatomic Patholo...Show moreLast updated: 17 days ago
    • Promoted
    Director of Labor & Delivery (RRMC) - Associate or Full Clinical Professor of OB / GYN

    Director of Labor & Delivery (RRMC) - Associate or Full Clinical Professor of OB / GYN

    University of California - Los Angeles (UCLA)Los Angeles, CA, United States
    Full-time
    Associate or Full Clinical Professor .The posted UC salary scales (https : / / www.The salary range for this position is $250,000-$350,000. This position includes membership in the health sciences co...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Associate Medical Director, Clinical Development

    Associate Medical Director, Clinical Development

    Arrowhead PharmaceuticalsLos Angeles, CA, US
    Full-time
    Arrowhead Pharmaceuticals, Inc.Nasdaq : ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them.Using a bro...Show moreLast updated: 12 hours ago
    • Promoted
    Associate Medical Director Needed! - $312,000! Metro Los Angeles

    Associate Medical Director Needed! - $312,000! Metro Los Angeles

    Adaptive Medical PartnersLos Angeles, CA, United States
    Full-time
    Dynamic Leader needed for Multi-Site Healthcare Organization with 20+ ProvidersLeave Your Legacy on an Established Organization as we Grow. Blended Role : We are seeking an Involved Director Interest...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Procurement

    Associate Director, Procurement

    InsideHigherEdLos Angeles, California, United States
    Full-time
    Associate Director, Procurement.University of California Los Angeles.The Associate Director of Campus Procurement reports to the Director / Chief Procurement Officer and is responsible for managing a...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Medical Writing

    Associate Director, Medical Writing

    ImmunityBioCulver City, CA, United States
    Full-time
    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 ...Show moreLast updated: 9 days ago
    • Promoted
    Campus Associate Director of Nursing, Academics

    Campus Associate Director of Nursing, Academics

    West Coast UniversityNORTH HOLLYWOOD, California, United States
    Full-time
    Come care with us at West Coast University! As an Academic Dean, Academics a certified Great Place to Work, you will guide nursing students to do more than change their own lives – you will help ch...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Medical Director

    Medical Director

    Covelo DirectLong Beach, CA, US
    Full-time
    Physician – Urgent Care / Occupational Medicine.Multiple Sites Across California.Eligible for Sign-On, Quarterly, and Monthly Performance Bonuses. Urgent Care and Occupational Medicine clinics...Show moreLast updated: 12 hours ago
    • Promoted
    Medical Director - Movement Disorders

    Medical Director - Movement Disorders

    Hoag Health SystemNewport Beach, CA, United States
    Full-time
    The Medical Director is pivotal in steering the Hoag Movement Disorders Program, dedicated to elevating care standards and community service. As a Hoag medical staff member, the role will span from ...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director of Clinical Epidemiology and Infection Prevention - UCLA West Valley 2025-2026

    Associate Director of Clinical Epidemiology and Infection Prevention - UCLA West Valley 2025-2026

    University of California - Los Angeles (UCLA)Los Angeles, CA, United States
    Full-time
    Associate Director of Clinical Epidemiology and Infection Prevention .The posted UC salary scales [https : / / www.The salary range for this position is $142,100-$429,000. This position includes membe...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Director

    Medical Director

    Ohana Pet Hospital of Agoura HillsAgoura Hills, CA, United States
    Full-time
    Ohana Pet Hospital is searching for experienced veterinarian to lead our team as Medical Director.We have four locations in Ventura, Agoura Hills and Santa Paula. with this role focusing on our Ago...Show moreLast updated: 8 days ago
    • Promoted
    Clinical Director - Behavioral Health

    Clinical Director - Behavioral Health

    Novaris SearchAnaheim, CA, US
    Full-time
    Novaris Search are working with a growth minded Behavioral Healthcare provider that specialise in.They are actively seeking an executive level. Ensure quality of patient care is optimum.Supervise an...Show moreLast updated: 15 days ago
    • Promoted
    Director of Development (MCWH)

    Director of Development (MCWH)

    MemorialCare Health SystemLong Beach, CA, United States
    Full-time
    Pay Range • : $139,859 / annually - $192,326 / annually.MemorialCare is a nonprofit integrated health system that includes four leading hospitals, award-winning medical groups - consisting of over 200 ...Show moreLast updated: 14 days ago
    • Promoted
    Regional Medical Director

    Regional Medical Director

    Southern Veterinary PartnersCulver City, CA, United States
    Full-time
    Mission Pet Health is searching for a new Regional Medical Director to support our hospitals in the northern part of LA, Las Vegas and St. The Regional Medical Director is responsible for setting th...Show moreLast updated: 30+ days ago
    • Promoted
    Director of Clinical Laboratory

    Director of Clinical Laboratory

    West Anaheim Medical CenterAnaheim, CA, US
    Full-time
    The Lab Director is responsible for the overall management of the clinical laboratory and / or multiple departments including, administrative, financial, compliance, quality improvement, technical, a...Show moreLast updated: 25 days ago
    • Promoted
    • New!
    Associate Director, Graduate, Clinical & Professional Programs

    Associate Director, Graduate, Clinical & Professional Programs

    University of Southern California (USC)Los Angeles, CA, US
    Full-time
    Associate Director, Graduate, Clinical & Professional Programs.Office of Student Accessibility Services (OSAS).The Office of Student Accessibility Services (OSAS) is the unit on campus responsible ...Show moreLast updated: 9 hours ago