Head of Quality Assurance

An international clinical research organization is seeking a senior Quality Assurance leader to provide independent quality oversight for its China operations and support the organization's continued development within a global Quality Management System.

The role will shape the China QA strategy and readiness roadmap, interpret local regulatory requirements within a global quality framework, and oversee risk-based QMS assessments, remediation, audits, inspection readiness and quality issue management.

You will partner with Clinical Operations, Regulatory Affairs, Safety, Data Management, Legal and global quality stakeholders to embed appropriate controls, protect trial participants and uphold data integrity.

The role also includes developing the local QA team and representing Quality in governance and client interactions.

Applicants should have a minimum of 15 years of Quality Assurance experience in a CRO, pharmaceutical, biotechnology or regulated clinical research environment, including 10 years in QA leadership within a global or matrixed organization.

Strong working knowledge of China GCP, applicable NMPA expectations and international GCP standards is essential, alongside proven experience in QMS governance, audits, inspections, investigations and CAPA oversight.

Due to the markets that this role will cover, professional fluency in Mandarin and English is required.

This is a senior opportunity for a credible, independent quality leader who can translate regulatory expectations into practical, risk-based controls.

For a confidential discussion, please get in touch.

CEI: R2090154 | Licence No.: 22S1313