Quality Assurance Manager (GCP)

About the role

This role involves establishing, maintaining and continuously improving the company's clinical research quality management system, including GCP procedures and quality management processes. You will develop and implement clinical research quality assurance plans in accordance with ICH-GCP, NMPA and FDA requirements, and provide quality and compliance oversight of key clinical trial activities.

Key responsibilities

• Establish, maintain and continuously improve the company's clinical research quality management system, including GCP procedures and quality management processes.
• Develop and implement clinical research quality assurance plans in accordance with ICH-GCP, NMPA and FDA requirements, and other applicable regulations.
• Provide quality and compliance oversight of key clinical trial activities, including protocol implementation, informed consent, participant protection, data integrity, investigational product management and safety reporting.
• Plan and conduct audits of investigator sites, contract research organisations (CROs), vendors, clinical databases, Trial Master Files (TMFs) and other critical clinical research activities.
• Follow up on audit findings, deviations, non-compliance and corrective and preventive actions (CAPA), assessing root causes, remedial actions and their effectiveness.
• Support quality management for the company's global multicentre clinical trials and clinical programmes in China, working closely with Clinical Operations, Medical Affairs, Pharmacovigilance, Data Management and Regulatory Affairs teams.
• Participate in the qualification, auditing and ongoing quality oversight of key vendors and third-party partners.
• Coordinate readiness for regulatory inspections and client audits, including document reviews, mock inspections, issue remediation and on-site inspection support.
• Deliver training on GCP, standard operating procedures (SOPs), data integrity and quality compliance to clinical research teams and relevant partners.
• Regularly assess clinical research quality risks and quality metrics, report significant quality issues to management and recommend improvements.

About you

• Bachelor's degree or above in Medicine, Pharmacy, Biological Sciences, Clinical Research or a related discipline.
• At least five years of quality assurance experience in GCP-regulated clinical research, including clinical trial auditing experience, with at least two years of experience in independent auditing and clinical quality management.
• Sound knowledge of ICH-GCP, China GCP, and NMPA and FDA regulations and guidelines relating to clinical research.
• Good understanding of the full clinical trial lifecycle, including TMF management, CAPA, deviation management, vendor management and regulatory inspection readiness.
• Strong skills in risk identification, problem analysis, report writing and cross-functional communication.
• Ability to conduct audits independently and exercise sound professional judgement on complex quality issues.
• Good communication and document comprehension skills in both Chinese and English. CET-6 or an equivalent level of English proficiency is preferred.
• Willingness to undertake occasional domestic and international travel.
• Quality management experience in Phase III clinical trials in oncology or ophthalmology (preferred).
• Experience supporting inspections by the FDA, NMPA or other regulatory authorities (preferred).