Global Clinical QA Manager — GCP, Audits & Compliance

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

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.