Deviation, CAPA & Change Management Senior Manager

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 Deviation, CAPA, & Change Management Senior Manager will be responsible for developing, implementing, maintaining and providing oversight of the following Quality Systems Programs: Deviation, CAPA, and Change Management. This position interacts cross-functionally across the ImmunityBio organization. The Deviation, CAPA, & Change Management Senior Manager will lead quality programs across multiple functional areas, providing program training and administration, program monitoring and reporting, and leadership in the resolution of quality issues.

Essential Functions

• Develop and implement effective Quality Systems programs to ensure compliance with clinical and commercial regulatory requirements and standards:
  • Develop and implement training to complement the programs
  • Manage system administration, system support, mentorship, guidance and training to cross-functional stakeholders
  • Monitor programs to ensure consistent execution in compliance with the global procedure
  • Track and trend quality data and provide reports to management, ensuring there is active on-going record management to meet timely closure and resolution of actions
  • Lead and support quality systems operational mechanisms.
• Review and approve non-product related, central function-owned deviations, CAPAs, and change controls as needed.
• Participate in or lead investigations, complaint response and CAPAs to successful resolution through close collaboration with Manufacturing, Facilities, CXOs, QC and Quality teams.
• Participate in or lead Change Control strategy direction through close collaboration with Manufacturing, Facilities, CXOs, QC and Quality teams.
• Perform periodic audits of ImmunityBio's Deviation, CAPA, and Change Management systems.
• Provide support and participate as the Subject Matter Expert for the Deviation, CAPA, and Change Management programs during audits and inspections.
• Identify and provide leadership for continuous improvement initiatives for ImmunityBio related to the Deviation, CAPA, and Change Management programs.
• Participate in internal audits.
• Perform other Quality related duties, as assigned.

Education & Experience

• Bachelor's Degree in a life sciences or engineering discipline with 10+ years of progressive experience in a GMP regulated Biologics or Pharmaceutical environment required; or
• Master's degree in a life sciences or engineering discipline with 8+ years of progressive experience in a GMP regulated Biologics or Pharmaceutical environment required.
• Experience in 21 CFR 210/211, 21 CFR 600/610, and 2001/83/EC required.
• 5+ years of experience using electronic quality systems (i.e. DMS, LMS, QMS) required.
• 2+ years of management experience leading cross-functional Quality projects / initiatives preferred.
• Experience in clinical and commercial phase pharmaceutical environment preferred.
• Experience with Contract Manufacturing Organizations preferred.

Knowledge, Skills, & Abilities

• Proficient in written and oral communication.
• Able to prepare written communications with clarity and accuracy. Must have strong authorship and be able to critically review reports interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be able to work independently with ability to complete projects with little or no supervision.
• Ability to effectively plan and organize project/program steps and ensure completion to meet schedules and deadlines.
• Strong problem solving and analytical skills including root cause analysis.
• Demonstrated ability to be detail oriented; while managing multiple projects simultaneously.
• Strong interpersonal skills with the ability to provide training, coaching, and team leadership for a variety of groups, programs and projects.
• Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, and project timelines.
• Must be proficient in Microsoft Office (Excel, Word, Access, Power Point, Visio) and Adobe Professional software.

Working Environment / Physical Environment

• This position works hybrid (combination on site and remote) in Los Angeles, CA
• Ability to gown and gain entry to manufacturing areas.
• Ability to sit at a computer terminal for an extended period of time.
• Flexibility in working schedule, i.e., off hours, second shift, weekend work, and work travel as required (~5% total FTE time)

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.

$140,000 (entry-level qualifications) to $168,000 (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.