Quality Assurance Manager (GCP)

Health Hope Pharma Limited; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

Health Hope Pharma Limited is seeking a seasoned Quality Assurance professional to lead the clinical research QA program in Hong Kong. Responsibilities include maintaining the GCP-compliant quality system and guiding audits across global trials.

The role demands five years of GCP QA experience, strong regulatory knowledge (ICH-GCP, NMPA, FDA), and excellent English/Chinese communication. Occasional travel may be required.

Qualifications

• Minimum 5 years in quality assurance for GCP-regulated clinical research.
• Experience in independent auditing and quality management.
• Strong communication and documentation skills in English and Chinese.

Responsibilities

• Establish and maintain the clinical research quality management system (GCP).
• Develop QA plans in accordance with ICH-GCP, NMPA and FDA.
• Provide QA oversight of clinical trial activities including protocol, consent, data integrity, safety reporting.
• Plan and conduct audits of sites, CROs, vendors, TMFs.
• Address audit findings with CAPA and root-cause analysis.

Skills

ICH-GCP knowledge

Audit planning/execution

Regulatory inspection readiness

Bilingual English/Chinese

Education

Bachelor’s degree or higher in Medicine/Pharmacy/Biological Sciences/Clinical Research

Job description

• 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.

Requirements

• 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.

Preferred Qualifications and Experience

• Quality management experience in Phase III clinical trials in oncology or ophthalmology.
• Experience supporting inspections by the FDA, NMPA or other regulatory authorities.
• Experience with global multiregional clinical trials (MRCTs), or experience working for a clinical trial sponsor or biopharmaceutical company.
• Professional certification in GCP auditing, quality management or a related discipline.