Quality Cluster Lead Computerized Systems

Quality Cluster Lead Computerized Systems

Full-time

Compensation: EUR  - EUR  - yearly

Santen is a specialized company with a proud 130-year heritage focused exclusively on eye health.

As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in ophthalmology and from the patient’s perspective.

We are looking for an experienced Quality Cluster Lead, Computerized Systems to lead Computerized System Quality activities across the EMEA region. In this role, you will ensure that SAP systems, electronic Quality Management Systems, IT infrastructure,and external service providers operate in a compliant and inspection-ready state. You will lead the EMEA Computerized System Quality Team, drive quality governance and continuous improvement, and work closely with DIT, SAP and global stakeholders.

What you will do

Manage the Santen EMEA Computerized System Quality Team, leading, coaching and developing team members, ensuring appropriate competency and GxP training, and managing budget, resources and priorities. Act as the first point of contact for Information System and Computerized System Quality compliance matters within EMEA.

Define and lead the strategy for Computerized System Quality oversight across SAP systems, including SAP S/4

HANA, MMDM and the SAP EMEA landscape, electronic QMS platforms such as Veeva, Track Wise and Docu Sign, IT infrastructure, cybersecurity and external service providers.

Ensure effective Quality Governance for the Santen EMEA SAP S/4

HANA solution, including compliant governance, validation approaches and lifecycle controls. Translate Quality requirements into system/application requirements and ensure risk-based decisions are applied to SAP changes and releases, while representing EMEA Quality in cross-functional and global SAP governance forums.

Hold overall responsibility for the effective and efficient application of Santen's GxP governance framework to computerized systems and supporting infrastructure across the EMEA region, ensuring compliance with applicable regulatory requirements and company standards.

Set direction and monitor the performance of SAP QM and Master Data quality activities, ensuring robust controls, data governance and sustainable compliance of quality-critical master data. Work closely with Master Data Management, IT/Digital and business stakeholders to drive harmonised data standards and consistent implementation across systems and service providers.

Drive continuous improvement in SAP QM processes, MDM data governance, Computerized System Quality Review and Validation processes. Ensure QA KPIs are retrieved from systems in a timely manner, SAP EMEA Quality and validation activities are completed on time, and SAP QM users are appropriately supported, coached and trained.

Lead or participate in EMEA Quality projects related to Computerized Systems and digital Quality, representing EMEA Quality in global Computerized System projects and ensuring regional requirements are addressed. Lead and support successful eQMS rollouts across EMEA in alignment with global strategies and regulatory expectations.

Provide Quality oversight for eQMS platforms and computerized systems across EMEA, including acting as a Docu Sign Key User and eQMS process owner for platforms such as Track Wise and Veeva. Support quality integration activities and ensure eQMS tools remain compliant with applicable regulations.

Ensure timely execution of Periodic Reviews for Computerized Systems, IT infrastructure and external service providers across EMEA. Lead or coordinate Computerized System risk assessments and…