Senior GCP Auditor

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure compliance with ImmunityBio's standard operating procedures, ICH guidelines, US FDA regulations, and clinical study protocols in GCP.

• Collaborate across various functional teams involved in Clinical Trials, including Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, and Data Management, to uphold compliance with the GCP Quality Management System and all relevant regulatory standards.

• Maintain readiness for inspections at all times.

• Regularly update the Clinical Trial Quality Management system to align with industry standards, guidance, and best practices.

• Contribute to the creation and evaluation of SOPs and other controlled documents, including forms, templates, and work instructions.

• Ensure adherence to SOPs and ICH GCP E6 (R2) standards.

• Oversee the incident management program through the monitoring of complaints, deviations, and CAPAs.

• Organize, plan, coordinate, and execute vendor/supplier audits, internal audits, compliance visits, for-cause audits, and clinical trial site audits.

• Prepare necessary documentation for audit activities, including audit plans, reports, certificates, and corrective action plans.

• Validate the accuracy of audit findings, compile written audit reports, and manage follow-up actions to ensure satisfactory resolution of non-compliance issues.

• Review final audit documents for precision.

• Evaluate trial-related documents such as protocols, protocol amendments, ICFs, pharmacy manuals, and CSRs.

• Apply regulations, guidance document requirements, and study protocol stipulations to clinical trial studies.

• Participate in resolving GCP compliance challenges within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.

• Facilitate training on company procedures, GCP regulations, and documentation systems to ensure adherence to company policies and regulatory standards.

• Maintain all relevant QA department spreadsheets for tracking deviations, CAPAs, complaints, audit findings, and audit files as necessary.

• Lead initiatives for maintaining inspection readiness at all times.

• Assist senior staff during regulatory inspections or audits.

• Represent the QA department in internal and external meetings that support clinical programs.

• Perform additional Quality-related tasks as assigned.

⛳️ Requirements

• Bachelor's Degree in a life sciences or engineering field with at least 7 years of experience in a GCP-Biologics or Pharmaceutical setting; or a 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 advantageous.

• Previous experience with TMF or electronic document management systems is a plus.

• Capability to effectively plan and organize work activities while prioritizing tasks to meet schedules and deadlines.

• Strong problem-solving and analytical skills with a proven ability to be detail-oriented while managing multiple projects simultaneously.

• Demonstrated understanding and application of ICH GCP E6 (R2).

• Proficient in both verbal and written communication.

• Ability to multitask across various functional areas.

🏝️ Benefits

• Options for Medical, Dental, and Vision Plans.

• Health and Financial Wellness Programs.

• Employer Assistance Program (EAP).

• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability.

• Flexible Spending Accounts for Healthcare and Dependent Care.

• 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 qualify for Unlimited PTO.

• Non-Exempt Employees are entitled to 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day.