Contracted GxP Auditor

Company Profile

We are a professional independent third-party clinical trial audit company headquartered in China , with profound expertise and extensive hands-on experience in domestic clinical trial auditing and GxP compliance services across the Chinese market. We have established long-term, stable partnerships with well-known pharmaceutical companies, CROs and clinical research institutions both domestically and worldwide, upholding the core principles of rigor, compliance, objectivity and independence. To support our clients’ global clinical development needs, we provide standardized, cross-border GxP audit solutions, helping clients ensure trial quality, adhere to international regulatory requirements, and achieve fully compliant project delivery.

Job Overview

This is a contract-based, project-focused GxP audit position (non full-time) , tasked with independently performing on-site and remote audits for Phase I-IV clinical trials locally within the candidate’s base region ( Australia, Europe, or the United States ), in accordance with client project requirements. The role requires strict compliance with ICH-GCP, FDA, EMA, TGA guidelines, global GxP standards and company internal SOPs, verifying trial compliance, data authenticity and integrity, and issuing professional, objective audit reports. Candidates must have a minimum of 5 years of hands-on clinical trial/GxP audit experience , with proficient knowledge of local audit workflows and regulatory rules in their resident region.

Key Responsibilities

1. Local GxP Audit Execution : Independently conduct on-site and remote GxP audits for local Phase I-IV clinical trials within the candidate’s base region (Australia, Europe or the US) per client project scopes, covering all mainstream clinical study types. Lead the complete audit process including pre-audit preparation, on-site implementation, finding documentation and closure follow-up.
2. Regulatory & GxP Compliance Verification : Strictly follow ICH-GCP, FDA, EMA, TGA regulations, international GxP standards and internal SOPs applicable to the local base region. Conduct comprehensive audits of core modules including protocol adherence, subject protection, raw data credibility, source document integrity, investigational product control and adverse event (AE) reporting, and accurately identify potential compliance risks.
3. Audit Reporting & Document Management : Draft professional, concise English audit reports with clear findings, risk classifications and actionable corrective suggestions; complete timely filing, sorting and archiving of all audit-related documents in line with local regulatory and client requirements.
4. On-site Communication & CAPA Follow-Up : Communicate efficiently and professionally with local research sites, client project teams and relevant stakeholders, track the progress of corrective and preventive actions (CAPA), verify the effectiveness of rectification, and ensure full closure of all audit findings.
5. Regulatory Update & Local Work Adaptability : Keep abreast of updated GxP and clinical trial regulatory policies applicable to the resident region; flexibly arrange local on-site audit schedules per project demands .

Job Requirements

1. Core Professional Experience : Minimum 5 years of hands-on clinical trial/GxP audit experience in a third-party audit agency, pharmaceutical company or CRO; solid local audit experience in Australia, Europe or the US.
2. Regional Audit Capability : Familiar with local regulatory requirements and site audit practices in your resident region (Australia / Europe / US); able to independently deliver full-process local clinical trial/GxP audits; relevant local on-site audit experience is strongly preferred.
3. Professional Knowledge & Qualifications : Proficient in ICH-GCP, FDA, EMA, TGA and global GxP standards; solid command of clinical trial quality control processes; valid GCP certification or relevant audit professional credentials is preferred.
4. Language Proficiency : Business fluent in English (oral and written), capable of independent on-site communication , English report writing and document review, with full adaptability to an English-speaking working environment; proficient in the local language of the base region (oral and written) ; Chinese proficiency (oral and written) is preferred for daily communication and coordination with the company team.
5. Educational Background : Bachelor’s degree or above in Clinical Medicine, Pharmacy, Nursing, Biomedical Science, Public Health or other related medical and pharmaceutical disciplines.
6. Core Competencies : Meticulous, impartial and responsible, with excellent stress tolerance; strong independent working ability, risk identification and local stakeholder communication skills; able to flexibly arrange local on-site audit schedules per project needs.
7. Other Requirements : Must be legally resident and based in United States , and capable of conducting local on-site audits within the resident region; accept contract-based, project-based employment arrangement .