5 дней назад
Quality Cluster Lead Computerized Systems (SAP)
82 715 - 113 730€
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Cluster Lead Computerized Systems (SAP): Leading computerized system quality activities across the EMEA region, covering SAP S/4HANA, eQMS platforms, IT infrastructure, cybersecurity, and external service providers with an accent on GxP compliance, validation, governance, and data quality. Focus on leading regional quality teams, managing risk-based system controls, supporting eQMS rollouts, and maintaining audit and inspection readiness.
Location: Hybrid in Amsterdam, Netherlands
Salary: EUR 82,715–113,730 yearly, depending on experience and location
Company
Global ophthalmology company focused on eye health products and services, with a presence in more than 60 countries and regions.
What you will do
- Lead, coach, and develop the EMEA Computerized System Quality Team, managing competency, GxP training, budgets, resources, and priorities.
- Define and oversee computerized system quality strategy across SAP S/4HANA, MMDM, Veeva, TrackWise, DocuSign, IT infrastructure, cybersecurity, and external service providers.
- Govern SAP quality, validation, lifecycle controls, risk-based change decisions, and SAP QM and master data quality activities across EMEA.
- Drive continuous improvement in computerized system reviews, validation, MDM data governance, QA KPIs, and user support.
- Lead or support eQMS rollouts, digital quality projects, periodic reviews, risk assessments, audits, and regulatory inspections.
- Act as the primary EMEA Quality interface with DIT, SAP, global stakeholders, and computerized system governance initiatives.
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 and regional Quality governance in multinational environments.
- Experience with regulatory inspections or authority interactions involving computerized systems.
- Strong knowledge of GMP Annex 11, GAMP 5, 21 CFR Part 11, and applicable medical device computerized system validation regulations.
- University degree in Pharmacy, Science, Engineering, Data Science, or a related discipline, with fluent English.
Nice to have
- Experience with Salesforce or similar eQMS platforms.
- Experience with multinational eQMS rollout projects.
- Strong intercultural awareness across Europe and Asia.
Culture & Benefits
- Hybrid working environment.
- Flexible ways of working and an inclusive physical and virtual workplace.
- Market-aligned base salary dependent on experience and location.
- Opportunity to contribute to global ophthalmology research, development, manufacturing, and commercial activities.
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