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. Pharmacist license is preferred.
- Extensive experience in GMP/GDP audits, including CAPA review and effectiveness evaluation.
- Strong understanding of PIC/S GMP, ICH Q7, ICH Q9, and ICH Q10 and QA operation experience (more than 15 years)
- Experience as a QA lead during regulatory inspections.
- Ability to design risk-based audit and quality KPI frameworks.
- Proven capability in SOP harmonization and document control using globalized computerized systems.
- Experience in QA training design, auditor development, and training effectiveness evaluation (e.g., Kirkpatrick model).
- Strong English/Japanese communication skills for meetings, documentation, and executive reporting.
- Knowledge of CSV, data integrity, and GMP computerized system implementation.
- Experience in cross-functional leadership, and organizational management in multicultural environments, including the following:
- Experience in identifying required skills and competencies by back casting from organizational objectives
- Experience in defining recruitment requirements (Job Descriptions), participating in candidate selection, and designing onboarding processes
- Experience in succession planning with a focus on key roles and successor development
- Experience in designing role- and level-based training frameworks (e.g., Technical, Leadership, Compliance)
- Ability to design communication strategies that take into account on-site resistance and cultural gaps
- Experience in cross-functional collaboration with multiple disciplines (e.g., QA, RA, Manufacturing, HR)
- Ability to clearly explain proposals and build alignment with executive and senior management
Preferred
Project management experience involving affiliates located in multiple countries; Project Management Professional (PMP) or equivalent qualification preferred.
