Quality Cluster Lead Computerized Systems

Location: Amsterdam, Netherlands

Salary: EUR 82,715–113,730 per year, depending on experience and location.

Company

hirify.global is a Japan-originated global eye-health company focused on ophthalmology products and services, with operations across more than 60 countries and regions.

What you will do

• Lead, coach, and develop the EMEA Computerized System Quality Team, managing competency, GxP training, resources, budgets, and priorities.
• Define and oversee computerized system quality strategy across SAP S/4HANA, MMDM, Veeva, TrackWise, DocuSign, IT infrastructure, cybersecurity, and external service providers.
• Ensure compliant governance, validation, lifecycle controls, risk-based change decisions, and quality oversight for SAP and eQMS platforms.
• Drive SAP QM, master data governance, periodic reviews, validation activities, quality KPIs, and continuous improvement across EMEA.
• Lead or support eQMS rollouts, computerized system projects, risk assessments, audits, and regulatory inspection readiness.
• Act as the primary EMEA Quality interface with DIT, SAP, global stakeholders, and Health Authorities.

Requirements

• 10+ years of industrial experience, including at least 3 years in pharmaceutical, biotech, or medical device environments.
• At least 5 years of experience in computerized system quality review and validation, including SAP, Veeva, and TrackWise.
• Experience leading cross-functional teams, regional quality governance, multinational projects, eQMS rollouts, regulatory inspections, or authority interactions.
• Strong knowledge of GMP Annex 11, GAMP 5, 21 CFR Part 11, and applicable medical device computerized system validation regulations.
• Advanced data analysis skills and the ability to make independent, risk-based quality and compliance decisions.
• B.A./B.Sc. or equivalent degree in Pharmacy, Science, Engineering, Data Science, or a related discipline; fluent English required.

Culture & Benefits

• Flexible ways of working and an inclusive physical and virtual workplace.
• Opportunity to contribute to eye-health products and services for patients, consumers, and medical professionals.
• Global collaboration across diverse teams and regions.
• Equal-opportunity employment and accommodation support during the recruitment process.