Regional Clinical Quality Assurance Head, APAC

Sandoz; Selangor; On-site; MYR 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Regional Clinical Quality Assurance Head for the APAC region. This pivotal role involves overseeing Clinical Quality Assurance activities, ensuring compliance with global regulatory standards, and maintaining a robust Quality Management System. You will lead GCP training initiatives and manage inspections, playing a crucial role in upholding the integrity of clinical operations. If you have a strong background in Clinical Quality Management and a passion for ensuring excellence in clinical practices, this opportunity is perfect for you.

Qualifications

• 10+ years of experience in Clinical Operations and Quality Management.
• Strong knowledge of GCP, EU and FDA regulations.

Responsibilities

• Build and maintain the regional/local CQA network and organization.
• Manage Competent Authority Inspections related to clinical development activities.

Skills

GCP Compliance

Clinical Quality Management

Regulatory Affairs

KPI Reporting

Education

Bachelor’s degree in Pharmacy

Master’s degree in Life Sciences

Tools

Audit Management System (GX-QEM)

Job description

Job Description

As the Regional Clinical Quality Assurance Head, APAC, you will be responsible for executing local and regional activities related to Clinical Quality Assurance oversight in Country Organizations and legal entities across APAC, in close collaboration with the global Development QA organization. Your role involves ensuring clinical compliance, inspection readiness of regional/local Clinical Operations and Medical Affairs, maintaining a fit-for-purpose Clinical Quality Management System (QMS) aligned with corporate standards, and collecting/reporting KPIs and KQIs to the relevant Quality Council.

Key Responsibilities

1. Build and maintain the regional/local CQA network and organization.
2. Ensure GCP trainings are conducted within the region or at local sites.
3. Plan and execute regular self-inspections of clinical and medical setups at Sandoz local sites or within respective countries.
4. Ensure compliance of local clinical studies.
5. Escalate high-risk GCP areas and issues to line managers and higher authorities, ensuring appropriate remediation actions are implemented.
6. Oversee local GCP External Service Providers.
7. Act as CAPA Coordinator or CAPA Approver within the audit management system (GX-QEM).
8. Manage Competent Authority Inspections related to clinical development activities (pre-/clinical).

Requirements

• Educational background: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Medical Science.
• Languages: Proficiency in spoken and written English is required; knowledge of Japanese and Thai is advantageous.
• Minimum of 10 years of professional experience, including at least 5 years in Clinical Operations, Clinical Quality Management, or Drug Regulatory Affairs.
• Strong knowledge of global regulatory frameworks, GCP, EU and FDA regulations, ICH guidelines, and quality standards.