QA Director

API CMO Management

• Oversee quality system assessment of CMOs and develop quality management strategies to ensure the quality system and quality management capabilities continuously meet HUTCHMED's expectations and requirements.

• Ensure effective management of API CMOs, including but not limited to participating in on-site audits (such as CMO quality audits, official GMP inspections, Pre-Approval Inspections), reviewing quality agreements, and evaluating annual quality management review reports.

• Ensure each batch of API is manufactured, tested, and released in accordance with approved documents and applicable regulatory requirements

• Ensure quality issues arising during API production and testing are properly addressed, with timely reporting to QA Head.

• Handle quality events including product complaint investigations, deviations, change controls, OOS/OOT, recalls, reprocessing, and rework.

• Review GMP documentation from CMOs to ensure compliance of GMP product documents

Material/Service Supplier Management

• Manage supplier selection, evaluation, qualification, and monitoring processes.

• Establish and maintain supplier audit processes and audit plans, implementing audits according to schedule.

• Establish supplier quality assurance agreement management processes and oversee drafting and signing of specific agreements.

• Communicate with suppliers regarding quality issues, track supplier quality problems, and implement corrective and preventive actions; regularly perform statistical analysis and trend reporting of supplier quality issues.

• Manage supplier change control assessments and activities, including related material evaluations and supplier qualification re-confirmation.

• Establish supplier files and participate in the maintenance and management of material master data.

• Supervise quality behaviors of relevant departments in the distribution of launched products to ensure compliance with NMPA regulatory requirements.

• Review master data of tier-1 distributors for launched products

• Handle all commercial product quality complaints.

• Handle all returns of launched products, including quality returns and commercial returns.

• Assist related departments in product recalls to ensure distributors cooperate with HUTCHMED's recall actions.

Team Development & Capability Building

• Coach and develop team members to strengthen GMP awareness, technical competence, and digital literacy, fostering a culture of innovation and continuous improvement.

• Build organizational competency in AI-enabled quality tools and digital quality systems to ensure sustainable adoption and effective utilization.

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Requirements

Education & Experience

• Bachelor's degree or above in pharmaceutical sciences or a relevant field.

• Minimum 15 years of experience in QA, Production, and/or QC within a pharmaceutical manufacturing site; multinational company experience preferred.

Regulatory & Technical Knowledge

• Solid GMP knowledge of non-sterile API and drug product, with working understanding of cGMP requirements across US, EU, and China regulations.

• Strong knowledge of Quality Risk Management (QRM) principles (ICH Q9) and risk-based approaches to quality decision-making.

Digital & AI Competency

• Proven experience in leading digital transformation initiatives within quality management, particularly with VEEVA Quality platform implementation and optimization.

• Demonstrated experience or strong strategic vision in applying AI and advanced analytics to quality management processes — including predictive analytics, automated trending, and intelligent decision support.

• Experience in establishing data-driven quality monitoring and early warning systems to proactively identify recurring deviations and systemic issues.

Leadership

• Strong leadership capability and strategic thinking; able to influence cross-functional stakeholders and drive organizational change.

Soft Skill

• Good communication skills.

• Fluent oral English and good written English skills.

• Good presentation capability.