EMEA Computerized Systems Quality Lead (SAP/eQMS)

Santen; Amsterdam; Hybrid; EUR 82,714,000 - 113,732,000; Full time

Benefits offered by this job

Competitive Salary

Job summary

Santen seeks an experienced Quality Cluster Lead, Computerized Systems to oversee quality activities for EMEA’s computerized systems, including SAP, electronic QMS platforms, and IT infrastructure. You will ensure compliance and inspection-readiness across systems and service providers.

You will drive governance, risk-based decision making, and continuous improvement in SAP QM, MDM governance, and eQMS rollouts, collaborating with DIT, SAP and global stakeholders to meet regulatory expectations.

Qualifications

• 10+ years of industrial experience, including at least 3 years in a pharmaceutical, biotech or medical device environment.
• At least 5 years of experience in Computerized System Quality Review and Validation, including SAP, Veeva and TrackWise.
• Experience in multinational companies and eQMS rollout projects in cross-functional environments, preferably involving platforms such as TrackWise, Veeva or Salesforce.
• Proven experience leading cross-functional teams and managing Quality governance at a regional level.
• Experience with regulatory inspections or authority interactions related to computerized systems.
• Advanced data analysis skills and the ability to make independent, risk-based Quality and compliance decisions.
• Strong knowledge and understanding of GMP Annex 11, GAMP 5, 21 CFR Part 11 and applicable medical device computerized system validation regulations.
• Proven ability to translate Quality requirements into practical solutions for EMEA functions, including DIT and SAP teams, ensuring compliance across EMEA activities.
• Pragmatic and practical problem-solving skills, combined with strong intercultural awareness across Europe and Asia.
• B.A./B.Sc. or equivalent university degree in Pharmacy, Science, Engineering, Data Science or a related discipline, with fluent English.

Responsibilities

• Lead the EMEA Computerized System Quality Team, coaching and developing team members and managing budget and priorities.
• Define and lead strategy for Computerized System Quality oversight across SAP systems, electronic QMS platforms, IT infrastructure and external providers.
• Ensure governance for SAP S/4HANA solution including validation approaches and lifecycle controls; represent EMEA in SAP governance forums.
• Ensure compliance with regulatory requirements and company standards across computerized systems and supporting infrastructure.
• Oversee SAP QM and Master Data quality activities, ensuring data governance and compliant master data.
• Drive improvements in SAP QM, MDM data governance, CSQ Review and Validation processes; ensure KPIs are captured timely.
• Lead/participate in EMEA quality projects on computerized systems and digital quality; roll out eQMS across EMEA.
• Provide quality oversight for eQMS platforms (TrackWise, Veeva, DocuSign) and integration activities.
• Ensure timely periodic reviews and participate in audits of systems, suppliers and service providers.
• Maintain readiness for Health Authority inspections and audits; support QA with documentation and SME input.
• Act as EMEA representative in global initiatives; reflect EU regulatory requirements in global processes.
• Interface with DIT, SAP and global stakeholders; integrate cybersecurity and IT governance into QMS.

Education

B.A./B.Sc. or equivalent in Pharmacy, Science, Engineering, Data Science or related, with fluent English

Job description

Santen seeks an experienced Quality Cluster Lead, Computerized Systems to oversee quality activities for EMEA’s computerized systems, including SAP, electronic QMS platforms, and IT infrastructure. You will ensure compliance and inspection-readiness across systems and service providers.

You will drive governance, risk-based decision making, and continuous improvement in SAP QM, MDM governance, and eQMS rollouts, collaborating with DIT, SAP and global stakeholders to meet regulatory expectations.