Senior QA Expert CSV & Data Integrity 80-100%

What you will do:

• Serve as the Data Integrity (DI) Ambassador for the Stein manufacturing site, leading DI assessments for deviations, driving compliance initiatives, and collaborating with global stakeholders to strengthen the site's data integrity culture.
• Lead and maintain Computerized System Validation (CSV) activities for MES (e.g. MODA), BMS (e.g. DeltaV) as well as production and laboratory equipment, ensuring systems remain compliant, qualified, and inspection-ready throughout their lifecycle.
• Oversee validation of computerized systems for equipment and infrastructure for routine activities as well as CAPEX Projects ensuring adherence to validation master plans, GMP requirements, and Lonza quality standards.
• Act as the key QA contact for CSV, providing expert guidance on validation strategies, document lifecycle management, compliance matters, and quality risk assessments.
• Partner with local and global teams to drive continuous improvement, support audits and inspections, manage deviations, CAPAs and change controls for routine as well as CAPEX Project activities and contribute to the development of robust quality and data integrity practices across the site.
• What we are looking for:
• Proven experience in Quality Assurance within a GMP-regulated environment, with a strong understanding of pharmaceutical quality systems and relevant compliance requirements.
• Hands-on expertise in Computerized System Validation (CSV), including the validation and lifecycle management of MES, BMS and automation systems such as MODA, DeltaV or similar platforms.
• Solid experience in deviation handling, change management, and quality risk assessment, with the ability to drive compliant and effective solutions.
• Fluent English skills and a collaborative, team-oriented mindset, enabling successful work in an international environment and effective partnership with cross-functional and global stakeholders.
• Experience in Data Integrity, health authority inspections and audits (e.g., FDA, Swissmedic), and German language skills are advantageous, helping you excel in a highly regulated manufacturing setting.
• About Lonza
• At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.