The Position
The Head of Global Computer System Assurance IT and Infrastructure APAC is responsible for ensuring that global, cross-functional computerized systems comply with regulatory standards across the APAC region. This role oversees quality governance for GxP-relevant IT infrastructure and applications, leading a team of QA professionals to implement validated systems aligned with the company's LeVA framework. It requires strategic leadership, regulatory expertise, and the ability to influence global stakeholders, driving innovation and future-ready validation strategies to support evolving business needs.
Duties & Responsibilities:
- Lead the regional GCSA IT & Infrastructure team, aligning with BI's corporate strategy and promoting a strong quality culture.
- Define and implement strategic validation concepts for emerging technologies such as AI, cloud, mobile apps, and IoT.
- Represent BI in regulatory inspections and industry forums, contributing to future-ready validation strategies.
- Drive continuous improvement of validation frameworks and governance structures for innovative technologies.
- Ensure validated and qualified status of IT infrastructure and application systems in compliance with GxP regulations.
- Provide quality oversight across business functions and ensure audit readiness, including for SaaS, IaaS, and PaaS providers.
- Oversee execution of Self-Inspections per the CSV Audit Universe and maintain relevant SOPs for global and regional compliance.
- Advise global, divisional, and local stakeholders on validation strategy and risk-based approaches.
- Collaborate with MSOs, SMEs, and QA units to ensure process compliance and business alignment.
- Encourage smart risk-taking and critical thinking across teams and projects.
- Foster cross-country collaboration within APAC, leveraging cultural insights to support strategic initiatives.
- Lead and develop a diverse, high-performing team with a focus on succession planning and personal growth.
- Promote a safe, inclusive work environment aligned with BI's Quality Culture and EHS principles.
- Role model BI's values and leadership behaviors.
Requirements:
- Bachelor's degree in (Bio)Pharmaceutics, Chemistry, Engineering, IT, or a related field Master's degree is a plus.
- Minimum 5 years of experience in a regulated industry, with at least 5 years in IT quality control.
- Over 3 years of leadership experience managing international, cross-functional teams, with a proven ability to drive innovation and foster a quality culture.
- Strong expertise in validation strategies for emerging technologies (e.g., AI, cloud, IoT, mobile apps) and modern IT infrastructures (SaaS, IaaS, PaaS).
- In-depth knowledge of global GxP regulations (e.g., 21 CFR Part 11, Annex 11, ICH Q9/Q10) and their application to IT systems.
- Familiarity with governance frameworks and innovative validation methodologies.
- Strategic and conceptual thinker with a proactive mindset, promoting smart risk-taking and continuous improvement.
- Excellent communication, negotiation, and stakeholder management skills, with the ability to influence senior leadership across cultures.
- Strong project management skills and a track record of delivering process excellence.
- Flexibility to operate across APAC and global environments, with willingness to travel.
- Chinese language proficiency is a plus, but not required.
