QA Director

Responsibilities: Quality System Management & Compliance • Oversee all GMP management programs and site operations to ensure full compliance with cGMP requirements across Chinese GMP, EU GMP, and 21 CFR Part 11/210/211, as applicable. • Lead the site Quality Management System (QMS), governing the full lifecycle of change control, deviation management, and CAPA — ensuring timely execution, effectiveness verification, and closure. • Coordinate and execute product recall procedures in alignment with regulatory requirements. • Lead preparation and coordination for Health Authority inspections (PAI, GMP inspections, etc.) and customer audits / third-party due diligence. • Establish and execute the self-inspection program, ensuring a risk-based annual plan is in place, execution is tracked, and findings drive continuous improvement of the quality system. Quality Risk Management & Continuous Improvement • Embed Quality Risk Management (QRM) principles — aligned with ICH Q9 — across all stages of the product lifecycle, from development through commercial manufacturing. • Conduct risk-based gap assessments against evolving regulatory requirements; develop and execute risk-prioritized improvement plans. • Chair periodic quality management review meetings to analyze key quality metrics (deviations, change controls, OOS/OOT/OOE, stability data, complaints, RFT, etc.) and drive data-informed improvement actions. • Sponsor the data integrity improvement program; identify potential integrity risks and implement corrective actions to minimize or mitigate them. Quality System Digitalization & AI Innovation • Advance the paperless quality management vision by driving deep utilization of the VEEVA Quality platform — to eliminate manual inefficiencies and strengthen compliance. • Champion lean management principles across the quality organization to streamline workflows, reduce waste, and accelerate cycle times for quality events. • Implement early warning mechanisms and predictive analytics leveraging AI and data-driven tools to proactively identify recurring deviations, systemic quality issues, and emerging trends before they escalate. • Lead the strategic deployment of AI-powered solutions within QMS, including AI-assisted root cause analysis, automated deviation trending, predictive quality analytics, and intelligent document review, to enhance operational efficiency and decision-making accuracy. 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. 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.