Director, Clinical, Preclinical, and Diagnostic Quality Assurance

ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory." The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio's resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guerin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.

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 an early-stage public biopharmaceutical company with a headquarters in Southern California.

* Work with a collaborative team with the ability to work across different areas at the company.

* Ability to join a growing company with development opportunities.

Position Summary

The Director, Clinical, Preclinical, and Diagnostic Quality Assurance ensures GLP, GCP, CAP/CLIA compliance with ImmunityBio Standard Operating Procedures (SOPs), ICH guidelines and US FDA regulations, and Preclinical and Clinical study protocols/plans. The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times for Clinical, Preclinical and Diagnostic testing.

Essential Functions

• Oversees the Quality Management System (QMS) for all functional areas (preclinical [including bioanalytical], clinical and diagnostic) to be current with industry standards, guidance and best practices
• Facilitates the development and review of SOPs and other controlled documents (forms, templates, work instructions)
• Manages, supervises and directs the Development QA team
• Assures compliance with SOPs, required standards, guidelines and regulations. Subject matter expert in electronic document control systems, i.e., Veeva Vault, etc.
• Oversees all audit and compliance related activities for both internal and external activities and directs future state initiatives.
• Ensures accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution
• Reviews the final audit documents for accuracy and successful close out of all audit reports
• Manages review of study related documents, e.g., plans/protocols, protocol amendments, ICFs, pharmacy manuals, validation plans/reports and CSRs reports, etc.
• Applies regulations which include but are not limited to GCP, GLP, 21 CFR Part 58 and 21 CFR Part 11, guidance document requirements, and study plan/protocol requirements to Preclinical and Clinical trial studies
• Resolve complex, escalated compliance issues within Quality Assurance and Preclinical/Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data management and Pharmacovigilance
• Supports joint efforts in training on company procedures, GLP and GCP regulations, and documentation systems to assure compliance with company Standards, SOPs, Work Instructions, etc. policies and regulatory standards
• Ensures timely maintenance and escalation of all associated QA department spreadsheets and metrics, tracking of deviations, CAPAs, complaints, audit findings, audit files and all study archives as applicable
• Ensures an updated and current QMS for the clinical, preclinical and diagnostic areas
• Leads efforts in development and implementation of inspection readiness at all times
• Maintains inspection readiness at all times for Clinical, Preclinical and Diagnostic testing.
• Oversees the implementation of quality initiatives such as Quality by Design (QBD)
• Represents QA department at internal and external meetings supporting Preclinical (including early phase bioanalytical testing) and Clinical programs. Serving as a resource regarding interpretation and application of quality requirements, concepts, and industry best practices within ImmunityBio.
• Oversees the development of QA departmental strategies and objectives
• Oversees archives for legacy and current studies
• Performs other duties as assigned

Education & Experience

• Minimum of a Bachelor's degree in a life sciences. Master's or higher degree preferred
• Minimum of 10 years of experience in Biotech or pharmaceuticals.
• Experience with GLP and GCP regulations in the Biologics or Pharmaceutical industries
• Experience in managing staff

Knowledge, Skills, & Abilities

• Complete understanding and application of ICH GCP E6 (R2)/(R3), GCP/GLP and CAP/CLIA regulations
• CQA or other audit certifications is a plus
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
• Proficient in both written and verbal communication
• Multitasks across multiple functional areas
• Timeline focused and flexible in their work scheduling to meet the demands of a multi-product biologic and pharmaceutical company.
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously
• Knowledge of Trial Master File (TMF) or Electronic Data Capture (EDC) systems is a plus

Working Environment / Physical Environment

• This position is a hybrid role based in California.
• Flexibility in working schedule, i.e., off hours, second shift, weekend
• 25-30% travel may be required

This position is eligible for a discretionary bonus and equity award. The 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.

$190,000 (entry-level qualifications) to $210,000(highly experienced

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.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.