Head GQS CSV & Digital Quality

Job Description Summary Job Description Summary Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Lead the enterprise-wide CSV & Digital Quality function, ensuring that Sandoz's GxP computerized systems, digital solutions, data platforms, AI capabilities and automation technologies remain compliant, inspection-ready, scalable, and business-enabling.

Provide an enterprise view across the end-to-end digital ecosystem, ensuring consistent governance, risk management, compliance, and lifecycle oversight from business requirements and solution design through implementation, operation, change management, and retirement. Drive Compliance by Design, Quality by Design, digital transformation and process simplification across Development, Manufacturing, Quality, Supply Chain and Commercial functions.

Job Description Major accountabilities:  Enterprise CSV & Digital Quality Leadership Define and execute the enterprise-wide CSV & Digital Quality strategy. Establish and maintain a long-term roadmap for digital quality capabilities and compliance frameworks. Provide enterprise-level oversight of GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies.

Act as the senior Quality advisor for digital transformation initiatives and emerging technologies. Represent Digital Quality during regulatory inspections, audits and governance boards. Enterprise Governance & Compliance Establish and maintain governance frameworks for computerized systems, AI solutions, cloud platforms, automation technologies and digital products. Ensure compliance with global GxP requirements, Annex 11, 21 CFR Part 11, Data Integrity principles, GAMP5, CSA and applicable AI regulations.

Define and drive risk-based validation and assurance approaches across the enterprise. Ensure inspection readiness and regulatory compliance throughout the digital solution lifecycle. End-to-End Digital Quality Oversight Maintain an enterprise-wide view of digital quality processes, systems, data flows and interfaces across functions. Ensure end-to-end oversight and alignment from business requirements, design and implementation through operation, monitoring and continuous improvement.

Drive harmonization, simplification and standardization of digital quality processes globally. Identify opportunities to leverage digitalization, automation and AI to improve compliance, efficiency and business outcomes. AI, Data & Automation Governance Establish and maintain governance for AI, Generative AI, advanced analytics and intelligent automation solutions. Ensure appropriate qualification, validation, monitoring and lifecycle management of GxP-relevant AI solutions.

Define controls for explainability, traceability, risk management and regulatory compliance. Provide quality oversight for automated and autonomous decision-support capabilities. Digital Portfolio & Business Partnership Provide strategic quality oversight for enterprise platforms and digital products. Ensure quality and compliance requirements are integrated throughout concept, design, implementation and operation.

Partner with Quality, Digital, IT and Business leaders to accelerate digital transformation while maintaining compliance. Support prioritization of digital investments from a quality and compliance perspective. Organization & Capability Development Build and develop a high-performing organization with expertise in CSV, Digital Quality, Data Integrity, AI Governance, Risk Management and Supplier Digital Compliance.

Define future capability needs and develop talent pipelines. Foster collaboration and communities of practice across Quality, Digital and IT organizations. Minimum R