IT Assurance Specialist

Global IT Assurance Leader Opportunity

The role of Global IT Assurance Leader is a strategic position that requires strong leadership and technical expertise. The individual in this role will be responsible for ensuring that global computerized systems comply with regulatory standards across the APAC region. This involves overseeing quality governance for GxP-relevant IT infrastructure and applications, as well as leading a team of QA professionals to implement validated systems aligned with the company's LeVA framework.

This leader will drive innovation and future-ready validation strategies to support evolving business needs. They will have a strong understanding of emerging technologies such as AI, cloud, mobile apps, and IoT, and will be able to define and implement strategic validation concepts for these technologies.

Additionally, the Global IT Assurance Leader will represent the company in regulatory inspections and industry forums, contributing to future-ready validation strategies. They will also drive continuous improvement of validation frameworks and governance structures for innovative technologies.

This is an opportunity for a highly skilled and experienced professional to take on a challenging leadership role and make a significant impact on the company's IT assurance strategy.

Required Skills and Qualifications

• 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.

Benefits and Requirements

• Competitive compensation package.
• Opportunities for career growth and development.
• Collaborative and dynamic work environment.

Please submit your application if you have the required skills and qualifications for this exciting opportunity.

Key Responsibilities

• Lead the regional GCSA IT & Infrastructure team, aligning with corporate strategy and promoting a strong quality culture.
• Define and implement strategic validation concepts for emerging technologies.
• Represent the company in regulatory inspections and industry forums.
• Drive continuous improvement of validation frameworks and governance structures.
• Ensure validated and qualified status of IT infrastructure and application systems in compliance with GxP regulations.

This role requires a unique blend of technical expertise, leadership skills, and business acumen. If you are a motivated and experienced professional looking for a new challenge, please submit your application for this exciting opportunity.