Regional Clinical Quality Assurance Head, APAC

Job Description Summary

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

Key Responsibilities:

• Build and maintain regional/local CQA network and organisation.
• Ensure GCP trainings in region or local site.
• Plan and execute regular self-inspections of clinical and medical set-up in Sandoz local site or region of respective countries.
• Ensure local clinical studies compliance.
• Escalation of high risk GCP areas and issues to line manager and higher, ensuring appropriate remediation actions are executed.
• Oversight of local GCP External Service Providers.
• Act as CAPA Coordinator or CAPA Approver in respective audit management system (GX-QEM).
• Competent Authority Inspection of clinical development activities (pre-/clinical).

Requirements:

• Education: Bachelor degree or master’s degree of Pharmacy, Life Sciences or Medical Science.
• Languages: Proficiency in English spoken and written is required. Knowledge of Japanese and Thai would be an added advantage.
• Minimum 10 years of working experience with 5 years’ experience in Clinical Operations or Clinical Quality Management or Drug Regulatory Affairs.
• Good knowledge of global regulatory framework, GCP experience, knowledge of EU and FDA regulations, ICH requirements and common quality standards.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.