Country Head of Quality Assurance

About the opportunity

A global clinical research organisation is establishing and growing its China business and is looking for a Country Head of Quality Assurance. You will be the senior in-country QA representative and provide independent quality leadership within the company’s global Quality Management System (QMS). You will turn China’s regulatory and legal requirements into practical, risk-proportionate controls, keep the business inspection-ready, and protect trial participants and data integrity as the organisation expands.

What you’ll do

Regulatory

• Act as the primary QA point of contact in China and own the global escalation pathway locally.
• Build and maintain the China QA strategy, roadmap and readiness plan, aligned with global quality strategy and a phased expansion.
• Lead risk-based assessments of the global QMS against China GCP and NMPA expectations, then agree remediation and track actions to closure.
• Apply quality-by-design and risk-proportionality principles, monitor regulatory intelligence, and use metrics and trend analysis to drive continuous improvement.

QMS

• Decide, with global process owners, where global requirements need a local supplement, work instruction, translation or tool.
• Set up controlled governance for translated QMS content, including translator qualification, review, approval and version control.
• Work with Clinical Operations, Regulatory, Safety, Data Management, IT, Privacy, Legal, Procurement and other functions to embed GxP and China-specific requirements.
• Provide independent oversight of computerised systems and data-integrity controls for China trial activity.
• Lead, coach and develop the local QA team as it grows, acting as process owner and QA approver for quality documents where needed.

Audits and inspections

• Lead or support internal, investigator-site, vendor and for-cause audits, and oversee responses to significant observations.
• Lead health authority inspection readiness and support inspection management, including CAPA verification.
• Make sure procedures, systems, training, records and vendors are ready before regulated activity starts or expands in China.

Quality issues management

• Oversee noncompliance, deviations, serious breaches and CAPAs, from investigation and root-cause analysis through to effectiveness checks, and lead Quality Event investigations as QA lead.
• Support the qualification and ongoing quality oversight of local vendors and delegated activities.
• Promote GCP and QMS training, speak-up behaviours and a strong quality culture.

Client interactions and governance

• Represent China QA in governance forums, client interactions, audits, inspections and bid defences.
• Lead Quality Agreement negotiations and provide GxP consultation to project teams.
• Set up country quality governance, metrics and escalation, while keeping QA independent from operational delivery.

What you’ll bring

• A postgraduate or equivalent degree in life sciences, pharmacy, medicine, quality management or a related field
• 15+ years of QA experience in a CRO, pharma, biotech or other regulated clinical research environment
• 10+ years in a QA leadership role in a global or matrixed organisation, acting as an independent quality partner to country leadership
• Proven line management experience
• Expert knowledge of ICH GCP, GVP, China GCP and NMPA requirements, plus working knowledge of international standards such as FDA, EMA and UK CTR
• Experience leading QMS gap assessments, risk-based remediation, audits, inspection readiness and CAPA oversight
• Experience hosting local regulatory inspections
• Experience with vendor oversight and outsourced GxP activities
• Professional fluency in Mandarin Chinese and English
• Eligibility to work in China, and the ability to travel within China and internationally
• Desirable: experience with computerised-system and clinical-data governance oversight, and membership of a quality-related professional organisation