Director, Quality Assurance – China

About the opportunity

A global, science-driven organisation in a highly regulated, data-intensive sector is hiring a senior Quality Assurance leader for its China operations. You will be the senior regional representative for the global quality function. You will provide independent quality leadership and make sure the China business operates compliantly within a global quality system.

This is a role for someone who combines deep China regulatory expertise with strong QA leadership and the ability to work effectively across cultures. You will turn local regulatory and legal requirements into proportionate, practical quality controls, keep the organisation inspection-ready, and protect trial participants and data integrity.

Key responsibilities

• Act as the senior in-country QA representative and primary quality point of contact for China, including the escalation pathway to global teams
• Develop and maintain the China QA strategy, roadmap and readiness plan, aligned with the global quality strategy
• Lead risk-based assessments of the global quality system against current China GCP and national regulatory expectations, and drive gaps to closure
• Decide how global requirements should be localised: local supplements, work instructions, translated documents or tools. Maintain governance of translated content
• Partner with Clinical Operations, Regulatory, Safety/Pharmacovigilance, Data Management, IT, Privacy, Legal and Procurement to build GxP requirements into the operating model
• Provide independent oversight of computerised systems and data-integrity controls
• Lead or support internal, investigator-site, vendor and for-cause audits
• Lead health-authority inspection readiness and support inspection management, including CAPA oversight
• Oversee quality events, deviations, serious breaches and CAPAs, including root-cause analysis and effectiveness checks
• Support qualification and oversight of local vendors and service providers
• Lead, coach and develop the local QA team as it grows
• Represent QA in client interactions, quality agreement negotiations, audits and bid defences
• Use metrics and trend analysis to drive continuous improvement and a strong quality culture

About you

Essential

• Strong GCP experience. Broader GxP experience helps, but GMP experience alone is not sufficient
• Strong pharmacovigilance (PV) experience
• Demonstrated expertise in China regulations and the local regulatory environment, including current China GCP and national authority expectations
• Significant QA experience, including leading QA professionals, processes and/or systems
• Strong audit and health-authority inspection experience, ideally including hosting inspections
• Strong English communication skills, with professional fluency in Mandarin and English
• Experience in a global, matrixed organisation and working effectively across cultures
• Postgraduate or equivalent degree in life sciences, pharmacy, medicine, quality management or a related discipline
• Willingness to travel within China as needed, and eligibility to work in China

Valued

• Prior people leadership experience (around five years is ideal, but strong overall experience will be considered)
• Experience in a clinical research organisation, pharma or biotech
• Background in training, coaching or giving feedback, to help explain complex topics to stakeholders
• Working knowledge of international GCP standards (FDA, EMA, UK)
• Experience with vendor oversight and computerised-system governance