Product Steward (Temporary)

Job Description

Sandoz is a general market leader in generic and biosimilar medicines, committed to increasing access to high-quality healthcare for patients worldwide.

As a Product Steward within the Manufacturing Science & Technology (MS&T;) organization, you will act as the technical owner of assigned products throughout their commercial lifecycle. You will maintain oversight of manufacturing process performance, ensure processes remain in a continued state of validation, and drive data-based process monitoring and continuous improvement initiatives.

In this role, you will collaborate closely with Production, Quality Assurance, Quality Control, Regulatory Affairs, Operational Excellence, and other technical functions to ensure process robustness, compliance, and sustainable product performance. You will serve as the key technical point of contact for product-related process knowledge and provide scientific and technical support for investigations, process improvements, validations, and technical changes.

Your responsibilities will include




- Act as the technical owner and subject matter expert for assigned products throughout their commercial lifecycle.
- Maintain oversight of process performance and capability through statistical analysis, data trending, and ongoing process verification.
- Create, maintain, and periodically review product-specific Quality Risk Analyses (QRA).
- Monitor critical process parameters and quality attributes to ensure products remain in a validated state.
- Review Annual Product Quality Reviews (APQRs) and assess the state of process control.
- Lead or support root cause investigations related to process deviations, complaints, OOE, and OOS events.
- Define, implement, and monitor effective CAPAs to prevent recurrence of process issues.
- Assess technical changes, evaluate risks and benefits, and support implementation activities.
- Author and support process validation documentation, including protocols

📌 Product Steward (Barcelona)
🏢 Biopharma Careers
📍 Barcelona