Job Description
Job Summary Responsible for strengthening and maintaining a consistent Quality Management System across affiliates in the Asian region, while coordinating with global, regional, and local stakeholders to ensure effective implementation and operational alignment. Key Accountabilities 1) Design and oversee risk-based GMP/GDP audit programs covering Asian LA (Sales sites and Manufacturing sites) 2) Review and approve local SOPs to ensure alignment with PIC/S GMP and Global SOPs. 3) Design and deliver regional QA training programs (including not only QA-related skill development but also career development program such as organizational management and mindset-building skills) and evaluate training effectiveness for Asian LA (Sales sites and Manufacturing sites). 4) Establishment and monitoring of common quality related KPIs for Asian LA (Sales sites and Manufacturing sites), and lead continuous improvement activities (e.g. Leading Asian Management Review Meeting) utilizing these KPIs. 5) Oversee introduction and operation of GMP-related computerized systems owned by Global Quality for Asian LA (Sales sites and Manufacturing sites) 6) Identification of QA related challenges and indication of solutions through establishment and operation of regular/ad-hoc communication with QA members in Asian LA (Sales Sites and Manufacturing Sites) 7) Ensure effective end-to-end change management across manufacturing, regulatory, and supply chain functions. 8) Lead quality issue management, including deviations, complaints, supply impact assessment, and recall risk escalation. 9) Operation of the RHQ organization, including setting and managing team policies and objectives; securing and developing resources required for business execution; establishing opportunities for communication with stakeholders; planning and implementing operational improvements; and maintaining and improving the workplace environment. Qualifications / Required Master’s degree in pharmacy, physics, or chemistry.
