Quality Cluster Lead Computerized Systems

Job description

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/4HANA, MMDM and the SAP EMEA landscape, electronic QMS platforms such as Veeva, TrackWise and DocuSign, IT infrastructure, cybersecurity and external service providers. Ensure effective Quality Governance for the Santen EMEA SAP S/4HANA 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 DocuSign Key User and eQMS process owner for platforms such as TrackWise 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 participate in or lead audits of computerized systems, suppliers and service providers. Ensure EMEA Computerized System audit and inspection readiness, including representing EMEA Quality during Health Authority inspections and audits, providing required documentation and SME support, and fostering a strong Quality mindset within and beyond the EMEA Quality organisation. Act as the EMEA representative within global computerized system and digital quality initiatives, ensuring EU regulatory requirements are appropriately reflected in global processes, standards, and implementations. Provide quality oversight and support to other regions, as applicable within the defined scope of responsibility. Act as the primary EMEA Quality interface with DIT, SAP and global stakeholders, and lead the integration of cybersecurity and IT governance requirements into the Quality Management System for computerized systems. What you will bring to the role 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. What we offer: Competitive Salary: A market‑aligned base salary starting from EUR 82.715,00 – EUR 113.730,00 depending on experience and location. Ready to make a difference? Apply today and help us shape the future of eye health. Grow your career at Santen A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in ophthalmology. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment. The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know. 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.