Senior Manager, Clinical Quality Assurance & GCP Compliance

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 Senior Manager, Clinical Quality Assurance and GCP Compliance 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 Senior Manager 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.

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.
• Oversee the performance of designated staff. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
• 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.
• Draft, revise, contribute and adhere to the development and review of Standard Operating Procedures (SOPs) and other controlled documents (forms, templates, work instructions)
• Performs other special projects and/or duties as assigned.

Education & Experience

• Bachelor's degree in a life sciences or engineering discipline with 7+ 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 5+ 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 in Early Phase (1-2) clinical trials required, Phase 3-4 preferred
• American Society of Quality Certified Quality Auditor (CQA) preferred.
• Experience hiring, training, and leading cross-functional teams 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 is hybrid (combination of on-site and 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.

$171,000 (entry-level qualifications) to $190,000 (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.