HSO way of working
In fulfilling our roles, we are
- Accountable for our own capabilities and development.
- Focused on delivering results without excuses, and
- Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.
We are looking for people who
- See beyond self and are impact focused.
- Consider the needs, challenges, and objectives of every person they interact with.
- Exhibit positive reinforcement to help others succeed.
Job Description
About the role
Job Title: Global Computer Systems Validation Architect
Works closely with and have impact on: Global Quality Assurance team, esp. QA Validation System Manager, Head of Departments, esp. Manufacturing and Supply Chain.
Function: Global IT
Work Location/Site: Singapore, Global Headquarters
Role Overview
The Global Computer Systems Validation Architect is responsible for executing computer systems validation (CSV) activities for all GxP-regulated systems globally at HSO. This includes supporting new system implementation projects and managing validation activities throughout the entire lifecycle of established systems. The role ensures compliance with regulatory requirements (FDA, EUMDR, MDSAP, etc.) and internal quality standards by applying established validation strategies and governance. Additionally, this position serves as a Subject Matter Expert (SME) to provide technology guidance to project teams and stakeholders.
Duties and Responsibilities
- Implement and execute CSV activities according to established policies, SOPs, and templates.
- Ensure adherence to validation lifecycle processes: planning, risk assessment, protocol execution, and reporting.
- Lead validation deliverables for new system implementations, upgrades, and periodic reviews of existing systems.
- Maintain documentation integrity and audit readiness for all validation activities.
- Act as SME for CSV-related technology considerations, advising on best practices and compliance requirements.
- Provide technical input during system design, configuration, and deployment phases.
- Work closely with system owners and IT teams to ensure compliance during system deployment and ongoing operations.
- Provide guidance to project teams on validation requirements and timelines.
- Identify potential compliance gaps during execution and escalate for resolution.
- Support internal and external audits related to CSV.
- Recommend process improvements and automation opportunities within validation execution workflows.
Requirements
Experience
- The candidate should have University Degree in information technologies or equivalent.
- Experience of 8-12 years in IT or Quality roles within a GxP-regulated environment.
- Hands-on experience in executing computer systems validation activities for both new implementations and established systems.
Skills/Accreditations
- Passion to work for a global medical technology organization.
- Experience in producing software documentation and business requirement documentation experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.
- Substantial experience with business process analysis and/or reengineering, in a GXP regulated environment (FDA, EUMDR, MDSAP, etc.)
- Experience with implementation of Enterprise Scale Quality (QMS), Documentation and Regulatory Information Management Systems (RIMS). Understanding of BPM, SOA, APIs, open data and microservices preferred.
- Proven experience with program and business process management principles, processes and tools.
- Understanding of the different types of agile principles, methodologies and frameworks, especially those designed to be scaled at the enterprise level.
- Knowledge of Master Data Management systems and ability to define organizational Common Data Model. Experience with data driven digital transformation preferred.
- Ability to multi-task in a flexible and effective manner.
- Exceptional soft and interpersonal skills, including teamwork, facilitation and negotiation in a multi-cultural environment.
- Excellent written, verbal, communication and presentation skills with the ability to articulate new ideas and concepts to technical and nontechnical audiences.
- Ability to balance the long-term (big picture) and short-term implications of individual decisions and organization goals.
- Knowledge of business models, operating models, financial models, cost-benefit analysis, budgeting and risk management preferred.
Academic Qualifications
- Bachelor's degree in IT accreditation or equivalent
Travel requirements
