Descripción de la oferta
Role: System Validation, Platform QualificationLocation: Spain(100% Remote)Client: InfosysSal: Market RangePermanent full-time positionRequirements and number of open positions3-5 years- 2 Positions in Open5-10 Years- 2 Positions in Open10+ years - 2 Positins in OpenRole OverviewWe are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs.Key Responsibilities• Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review)• Drive validation strategy for enterprise programs across regions (Europe/Global)• Manage validation teams, allocate work, and ensure timely delivery• Act as primary point of contact for client stakeholders and leadership• Lead governance, status reporting, and escalation management• Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report)• Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+)• Manage quality processes (Deviation, CAPA, Change Control)• Support regulatory audits and inspection readiness• Mentor and coach junior resources, build capability within the team• Drive continuous improvement and standardization of validation processesManagerial Skills• Team leadership and people management• Stakeholder and client relationship management• Program and project management for global validation initiatives• Risk and issue management with mitigation planning• Resource planning and capacity management• Governance, reporting, and executive communication• Budget awareness and delivery management• Cross-functional coordination across IT, QA, Business and VendorsRequired Skills & Competencies• 10+ years of experience in Life Sciences CSV/CSA• Exposure to cloud/SaaS validation• Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.)• understanding of SDLC and validation lifecycle• Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.)• Experience in risk-based validation and CSA approach• Experience working with US and European clients and regulated environments• Strong documentation, communication, and leadership skills.
