Senior Specialist, Clinical Quality Assurance - Hybrid

Position Summary

The Senior Specialist, Clinical Quality ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols.

This position interacts cross-functionally with functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements.

This role is responsible for maintaining inspection readiness at all times.

Essential Functions

• Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
• Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
• Ensures compliance with SOPs and ICH GCP E6 (R2) standards.
• Manages the incident management program through monitoring of complaints, deviations and CAPAs.
• Schedules, plans, coordinates, and conducts vendor / supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits.
• Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans
• Validates 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.
• Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs
• Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies.
• Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
• Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
• Maintain all associated QA department spreadsheets tracking of deviations, CAPAs, complaints, audit findings, and audit files as applicable.
• Lead development and implementation efforts for inspection readiness at all times.
• Assists senior staff during regulatory inspections or other audits.
• Represents QA department at internal and external meetings supporting clinical programs.
• Performs other Quality related duties, as assigned.

Education & Experience

Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment;

or Master’s degree in a life sciences or engineering discipline with a minimum of 4 years’ of experience in a GCP-Biologics or Pharmaceutical environment.

• CQA or other audit certifications are a plus.
• Prior TMF or electronic document management systems experience is a plus.

Knowledge, Skills, & Abilities

• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
• Strong problem solving and analytical skills with demonstrated ability to be detail-oriented, while managing multiple projects simultaneously.
• Demonstrated understanding and application of ICH GCP E6 (R2)
• Proficient in communication both verbal and written
• Multitasks across multiple functional areas
• Timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company.

Working Environment / Physical Environment

• This is a hybrid role required to work on site 2-3 times per week
• Flexibility in working schedule, i.e., off-hours, second shift, weekends
• 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.

$120,000 (entry-level qualifications) to $150,000 (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.
30+ days ago