Global Clinical Governance Lead

2 weeks ago


Klang, Selangor, Malaysia Sandoz International GmbH Full time

This role plays a critical part in ensuring the clinical governance and compliance of Sandoz International GmbH's operations in the Asia-Pacific region.

The Regional Clinical Quality Assurance Head, APAC will be responsible for execution of local/regional activities of Clinical Quality Assurance oversight in Country Organizations/legal entities in APAC.

Key responsibilities:

  • Implement a comprehensive risk-based approach to identify and mitigate potential risks to clinical trials.
  • Develop and maintain a regional/local CQA network and organisation.
  • Ensure GCP trainings are conducted 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.
  • Collaborate with local Country Organizations/legal entities to ensure local clinical studies comply with regulatory requirements.
  • Oversight of local GCP External Service Providers is crucial to the success of this role.
  • Act as CAPA Coordinator or CAPA Approver in respective audit management system (GX-QEM).

Requirements:

  • A Bachelor degree or master's degree in Pharmacy, Life Sciences or Medical Science is essential.
  • 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.

About Sandoz:

Sandoz International GmbH has a long history of providing high-quality medicines to patients around the world.



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