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 current 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
📌 Head GQS CSV (Kalwe)
🏢 Sandoz
📍 Kalwe