Senior GCP Auditor

Role Summary

The Senior GCP Auditor ensures GCP compliance with SOPs, ICH and US FDA regulations and guidelines, and clinical study protocols. This role interacts cross-functionally with Clinical Trials teams to ensure compliance with the GCP Quality Management System and applicable regulatory requirements, and is responsible for maintaining inspection readiness at all times.

Responsibilities

• Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
• Contribute to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
• Ensure compliance with SOPs and ICH GCP E6 (R2) standards.
• Manage the incident management program through monitoring of complaints, deviations and CAPAs.
• Schedule, plan, coordinate, and conduct vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits.
• Prepare required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans.
• Validate the accuracy of audit findings, produce written audit reports, and follow up to ensure non-compliance issues are resolved satisfactorily.
• Review final audit documents for accuracy.
• Review trial-related documents (protocols, amendments, ICFs, pharmacy manuals and CSRs).
• Apply regulations 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 training on company procedures, GCP regulations, and documentation systems to ensure regulatory compliance.
• Maintain QA department spreadsheets tracking deviations, CAPAs, complaints, audit findings, and audit files as applicable.
• Lead development and implementation efforts for inspection readiness at all times.
• Assist senior staff during regulatory inspections or other audits.
• Represent QA at internal and external meetings supporting clinical programs.
• Perform other quality-related duties as assigned.

Qualifications

• 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 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.

Skills

• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Strong problem solving and analytical skills with attention to detail while managing multiple projects.
• Understanding and application of ICH GCP E6 (R2).
• Proficient in verbal and written communication.
• Multitasks across multiple functional areas with timeline-focused scheduling.

Education

• Relevant degree as listed in Qualifications (life sciences or engineering).

Additional Requirements

• Remote work environment.
• Flexibility in working schedule (off-hours, second shift, weekends).
• Approximately 25%–30% travel may be required.