Manager GQS CSV & Digital Quality

About the role

Serve as a senior subject matter expert for Computerized System Validation (CSV), Digital Quality, Data Integrity, AI Governance and digital compliance across the Sandoz organization. Provide quality and compliance oversight for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies throughout their lifecycle.

What you'll do

• CSV & Digital Quality Oversight
• Provide quality oversight and guidance for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies
• Support implementation and maintenance of CSV and Digital Quality frameworks, standards and procedures
• Ensure validation and compliance activities are conducted in accordance with applicable regulatory requirements and internal standards
• Contribute to regulatory inspections, audits and remediation activities related to computerized systems and digital solutions

What you need

• 10–15 yrs of experience
• Stakeholder management
• LLMs
• SAP
• ERP
• Process improvement
• Change management
• Any graduate

Good to have

• GMP
• SOP writing