Senior GCP Auditor: Quality & Compliance Leader

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

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.