岗位职责：

Audit Execution & Oversight

•Plan, conduct, and report on internal and external audits (e.g., investigator sites, vendors, systems) in accordance with GxP and company SOPs

•Conduct document audits including, but not limited to Common Technical Document (CTD), Clinical Study Report (CSR) and Nonclinical Study Report (NCR), electronic Trial Master File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications

•Lead and support the end-to-end CAPA process for internal and external audits, including root cause analysis, CAPA plan development, implementation tracking, and effectiveness checks

•Collaborate with business and study function representatives to review and agree on CAPA actions, submit responses to Quality Approvers, and ensure timely completion of CAPAs.

•Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.

•provide oversight of external audit contractors, ensuring alignment with internal SOPs and quality expectations, including review of deliverables, confirm completeness and correctness of audit outputs, and ensure timely reporting and CAPA closure

•Work closely with internal stakeholders to evaluate the performance of audit contractors, ensure alignment with quality expectations, and coordinate audit scheduling to meet programme timelines and compliance priorities.

Metrics, Trends & Analysis

•Develop and maintain dashboards and reports on audit findings, CAPA status, and compliance trends across regions and programs

•Analyse audit data to identify signals, recurring issues, and areas for improvement; present findings to the GxP Risk Council and cross-functional leadership.

Inspection Readiness & Regulatory Intelligence

•Coordinate and participate in inspection readiness activities and contribute to regulatory knowledge-sharing sessions and training forums

•Stay current with global regulatory developments and integrate learnings into audit planning and execution.

•Design and implement China-specific self-inspection tools and initiatives in collaboration with QA teams, internal cross- function stakeholders to proactively mitigate compliance risks.

•Be the primary/ secondary inspection management lead for Health Authority inspections (China), including Site/CRO "For Cause" audits

Stakeholder Engagement

•Collaborate with global QA teams, business functions, and external partners to harmonise audit practices and promote a quality culture

•Present audit insights and strategic recommendations to senior leadership and governance forums (e.g., Quality Review Board)

Process Improvement

•Contribute to the development and revision of SOPs, audit related SOPS, tools, manuals and templates to enhance audit effectiveness and efficiency

•Participate in initiatives such as the Guest SME Programme and site and vendor risk assessments

Onboarding & Development

•Actively mentor new auditors through structured onboarding programmes, including orientation, hands-on practice, and peer feedback sessions

资历要求：

• Bachelor's Degree in Life Sciences, Pharmacy or Medicines required. Master's Degree advanced degree in Life Sciences, Pharmacy or Medicines preferred.
• 2 or more years of GCP Lead Auditing experience; additional GVP Auditing experience is preferred
• Experience in preparing, hosting and following-up health authority inspections
• Understanding of global expectations of Health Authorities in management of clinical trials and post marketing studies.
• Profound knowledge of China local & international GCP, GVP regulations and guidelines and current industry practice.
• Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders.
• Strong communication skills across all levels of management and outside the company.
• Ability to lead and communicate fluently and effectively- verbal, written and in formal presentations in both Chinese and English
• Effective project and time management skills and the ability to work under pressure.
• Experience in vendor oversight is preferred语言水平Native Chinese language skill
• Good English language skills (written and verbal)能力要求Integrity and high ethical standards
• Analytic and systematic approach with good problem-solving skills
• Demonstrates effectiveness in working in a multidisciplinary and matrixed environment
• Proactive and reliable working style paired with the ability to work in international matrix teams
• Ability to understand complex matters with a continuous focus on improvement
• Substantial communication skills, also on intercultural level with respect and appreciation of cultural diversity
• Flexible and adaptable
• Good communication skills and intercultural sensitivity.
• MS Office 365/ MS Teams