CSV Validation Lead - GxP

You will join a high-performing, globally distributed team working on Basecamp 2.0, a strategic digital platform within Roche Technical Operations aimed at reducing technology transfer cycles between Drug Development and manufacturing sites for faster, reliable, and compliant delivery of medicines.

• Minimum 3+ years of experience in IT & Software Validation (CSV, GAMP), preferably in the pharmaceutical industry
• Strong experience in Agile and/or Lean methodologies
• Hands-on experience in leading validation activities and system maintenance
• Proven ability to author and review validation plans, reports, and related documentation
• Strong understanding of SDLC within regulated environments (pharma or similar industries)
• Experience with regulated compliance frameworks (FDA 21 CFR Part 11, EU Annex 11)
• Familiarity with SAP and MES systems and their integrations
• Experience with Jira (backlog management) and ServiceNow (incident/change/knowledge management)
• Strong analytical skills with attention to detail and accuracy
• Excellent communication skills in English (C1 level minimum)
• Ability to work effectively in cross-functional and global teams
• Strong ownership, persistence, and ability to manage stakeholder dependencies
• Higher education degree in Computer Science, Software Engineering, Information Systems, or related field
• Scrum or SAFe certification is a plus (or willingness to obtain within 6 months)

• Collaborate closely with Product Owners, Scrum Masters, Architects, Developers, Business Owners, and Test Leads
• Define validation strategies and identify required deliverables for GxP computerized systems
• Review software and validation documentation in accordance with corporate CSV SOPs and regulatory requirements
• Estimate and plan validation activities for projects and system enhancements
• Author validation plans, validation reports, and review test documentation for release readiness
• Ensure compliance with corporate quality standards in collaboration with Quality and Informatics teams
• Coordinate validation activities across global teams and systems
• Provide expert consultancy on validation topics, testing activities, and deviation handling
• Lead system and functional risk assessments
• Support system implementation, maintenance, and validated state assurance
• Ensure audit readiness and support inspections as a CSV subject matter expert
• Lead periodic system reviews and change impact assessments
• Oversee data migration and production release validation activities
• Contribute to process optimization, governance improvements, and validation framework development
• Support training and knowledge sharing within the organization
• Provide input into system retirement and lifecycle planning