Senior GCP Auditor

Jobtailor; El Segundo (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Jobtailor in California is seeking a seasoned QA professional to manage the Clinical Trial Quality Management System and drive audit programs across sites and vendors.

The role emphasizes ICH GCP E6 (R2) compliance, SOP development, CAPA handling, and cross-functional collaboration with Regulatory Affairs, Clinical Operations, and Pharmacovigilance. Willingness to travel 25–30% and CQA certification are preferred.

Qualifications

• Bachelor’s or Master’s degree in life sciences or engineering; minimum 7/4 years in GCP-biologics/pharma.
• Knowledge of and ability to apply ICH GCP E6 (R2).
• Strong problem solving and analytical skills.
• Detail-oriented with ability to manage multiple projects.
• Proficient verbal and written communication.

Responsibilities

• Maintain and update the Clinical Trial Quality Management System.
• Contribute to SOP and controlled document development/review.
• Ensure compliance with SOPs, ICH GCP E6 (R2), regulations and study protocols.
• Manage incident management programs covering complaints, deviations, and CAPAs.
• Plan, coordinate, and conduct vendor, supplier, internal, compliance, for-cause, and site audits.
• Prepare audit plans, reports, certificates, and corrective action plans.
• Validate audit findings and follow-up activities to resolve non-compliance issues.
• Review trial-related documents including protocols, amendments, ICFs, CSRs; apply regulatory requirements.
• Participate in resolving GCP compliance issues across QA, Clinical Ops, Regulatory, Medical, PV.
• Support training on procedures, GCP regulations, and documentation systems.
• Maintain QA spreadsheets tracking deviations, CAPAs, complaints, and audit files.
• Lead inspection-readiness development and implementation.
• Assist senior staff during regulatory inspections and audits.
• Represent QA at internal and external meetings supporting clinical programs.
• Perform ad-hoc and cross-functional duties and projects.

Skills

Problem Solving

Analytical Skills

Detail-Oriented

Verbal Communication

Written Communication

Project Management

Regulatory Compliance

Audit Planning

Quality Assurance

GCP Knowledge

Education

Bachelor’s Degree in Life Sciences or Engineering

Master’s Degree in Life Sciences or Engineering

Tools

TMF Systems

Electronic Document Management

QA Spreadsheets

Job description

• Maintain and update the Clinical Trial Quality Management System


• Contribute to development and review of SOPs and controlled documents


• Ensure compliance with SOPs, ICH GCP E6 (R2), regulations, guidelines, and clinical study protocols


• Manage incident management programs covering complaints, deviations, and CAPAs


• Schedule, plan, coordinate, and conduct vendor, supplier, internal, compliance, for-cause, and clinical trial site audits


• Prepare audit plans, reports, certificates, and corrective action plans


• Validate audit findings and follow-up activities to resolve non-compliance issues


• Review final audit documents for accuracy


• Review trial-related documents including protocols, amendments, ICFs, pharmacy manuals, and CSRs


• Apply regulatory, guidance, and protocol requirements to clinical trials


• Participate in resolving GCP compliance issues across Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance


• Support training on company procedures, GCP regulations, and documentation systems


• Maintain QA spreadsheets tracking deviations, CAPAs, complaints, audit findings, and audit files


• Lead inspection-readiness development and implementation


• Assist senior staff during regulatory inspections and audits


• Represent QA at internal and external meetings supporting clinical programs


• Perform ad-hoc and cross-functional duties and projects

Requirements

• 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


• Knowledge of and ability to apply ICH GCP E6 (R2)


• Understanding and application of ICH GCP E6 (R2)


• Strong problem solving and analytical skills


• Detail-oriented ability while managing multiple projects simultaneously


• Proficient verbal and written communication


• Ability to multitask across multiple functional areas


• Timeline-focused and flexible work scheduling


• Ability to plan and organize work activities and prioritize task completion


• CQA or other audit certifications preferred


• Prior TMF or electronic document management systems experience preferred


• Flexibility to work off-hours, second shift, and weekends


• Ability to travel 25%-30%

Core Competencies

Demonstrates expertise in Clinical Trial Quality Management, ensuring compliance with ICH GCP E6 (R2) and managing audit processes. Proficient in developing SOPs, conducting audits, and applying regulatory requirements to clinical trials.

Highest-signal resume keywords

• ICH GCP E6 (R2) Compliance


• Clinical Trial Auditing


• SOP Development


• Incident Management


• CQA Certification

ATS Optimization Keywords

Hard Skills

• Clinical Trial Quality Management


• SOP Development


• Audit Planning


• Regulatory Compliance


• Incident Management


• Data Analysis


• Document Review


• Corrective Action Plans


• Quality Assurance


• Project Management

Soft Skills

• Problem Solving


• Analytical Skills


• Detail-Oriented


• Verbal Communication


• Written Communication

Certifications & Qualifications

• CQA Certification

Industry Keywords

• GCP-Biologics


• Pharmaceutical Environment


• Regulatory Affairs


• Clinical Operations


• Pharmacovigilance

Tools & Technologies

• TMF Systems


• Electronic Document Management Systems


• QA Spreadsheets