Jessica hu, MBA, DM

• Lead 80+ RAQA professionals across 13 APAC markets (ANZ, Japan, Greater Asia, China); 10 direct reports • Own 350+ drug licenses + 2000+ device licenses; accelerated approvals by 3–5 months in China/Korea/Taiwan, driving early market launch • Single point of contact for APAC RAQA governance; achieved zero major findings in all MOH & corporate audits • Oversaw 24 3PL warehouses; drove compliance improvement and quality oversight • Led 100% RIM system rollout across APAC; built regional SME network and cross-country audit framework • Shaped regulatory policy and industry standards to strengthen Baxter’s APAC influence Implements processes and policies to achieve financial and strategic goals. • Engages with regulators to support commercial plans and influence regulatory trends. • Oversees regional Quality Management Systems (QMS) and ensures compliance with changing regulations. • Champions efficiency, cost reduction, and quality improvement initiatives, leveraging AI, technology, and data analytics. • Optimizes organizational structure and manages QARA talent, focusing on attracting, retaining, and developing high-performing teams. • Strategic and proactive leadership, develop and implement regional QARA strategies and plans that: drive significant improvements and a culture of excellence, are aligned with Regional and Enterprise business strategic priorities, and deliver a Patients First culture

• Led 50+ RAQA team across 13 countries; promoted 3 high-potential talents to leadership roles • Served as APAC RAQA Lead for Baxter Spin-off (2023–2024); ensured on-time launch across all markets with no RAQA delays • Established new legal entity QMS, certification, and TSA/rTSA implementation; passed all audits • Selected as 1 of 12 Global RAQA Change Champions for enterprise-wide transformation • Built team succession plan; achieved 90% manager effectiveness within 1 year • Engages with regulators to support commercial plans and influence regulatory trends. • Oversees regional Quality Management Systems (QMS) and ensures compliance with changing regulations. • Champions efficiency, cost reduction, and quality improvement initiatives, leveraging AI, technology, and data analytics. • Optimizes organizational structure and manages QARA talent, focusing on attracting, retaining, and developing high-performing teams. • Strategic and proactive leadership, develop and implement regional QARA strategies and plans that: drive significant improvements and a culture of excellence, are aligned with Regional and Enterprise business strategic priorities, and deliver a Patients First culture

•Led 400+ team members (10 direct reports); reported to Global CQO and joined GQLT • Oversaw quality compliance for 5 manufacturing sites, China R&D, and commercial operations (China/Hong Kong/Taiwan) • Drove QMS optimization for “Made in China” strategy; led particle matter control task force with verified market improvement • Boosted team performance from 78% to 90% in 2 years; executed talent retention and succession planning • Led end-to-end quality governance: complaint vigilance, CAPA, audit readiness, and regulatory escalation

Responsbile for quality function and system setup for a green field project. Successful setup robust QMS system with successful ISO 13485: 2016 certificate inspection without finding in 2018 with design and development and manufacturing in the scope of certificate. Has been setup an fully engaged team with 20 around team members. Have been setup robust interface with Germany QMS to ensure the criticial QMS elements are engaged from both site together. Has been awarded as individual award of 2018 global Quality and Regulatory "above and beyond" award. As one of ten key contributor represent AMS project is awarded as " 2019 Roche excellence " Award.

Resposible for QA oversight and Quality system implmentation in Region.Novartis OTC Greater China(including Hongkong, Taiwan, China) and Korea. Responsible for third-party suppliers' management, product transfer QA oversight, country quality risk assessment and control the risk.

Responsible for site QA compliance function. Take the lead of site quality culture, and take the site to pass MHRA, WHO, TGA inspection in year 2008, 2009 and 2011 with only minor observations supportd by functions and team

Build up site validation systems which is fufillled the requirements from MHRA. No observation from MHRA in year 2008.

Responsible for the testing of assay of Vitamin, Cl, P and heavy metals. Familiar with the Quality management system in Nestle. Responsible for written the Sop and product specification. Testing all kinds of products manufactured in Nestle AP area(including milk powder, chocolate, coffee, ice Cream, corns, liquid milk, etc). Calibration activities for analytical equipments.

Responsible for the testing of tablet and capsules, Including the test for raw material, bulk, finish goods , Stability tests for finish goods and develop new analytical method for new product. Analytical equipment qualification and analytical method validation. Familiar with all kinds of analytical equipments used in pharmaceutical sites Lab, got the knowledge of calibration and doing simple maintenance for analytical equipments.

Responsible for equipment analysis. Assist Professor develop the analytical method for new product, doing analytical method validation. Familiar with and can be used frequently For kinds of analytical equipments including: HPLC, GC,UV, and IR.