Senior Quality Systems Architect (m/f/d)

Introduction

We are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market.

This benefits not only our partners, but also patients around the world. We are proud that our specialised business model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘ ACHIEVE MORE ’.

What makes your day with us special:

• Design and further develop the global Quality Management System, including processes for deviations, CAPA, and documentation
• Implement, validate, and continuously improve electronic quality systems (eQMS) and related platforms
• Maintain and continually improve existing quality systems to ensure compliance with regulatory requirements.
• Ensure alignment with relevant international GxP regulations, such as ICH Q10, EU GMP/GVP/GCP/GDP, 21 CFR, and Regulatory regulations
• Ensure compliance with international GxP regulations and drive data integrity initiatives across quality systems
• Coordinate cross-functional stakeholders and lead interactions with regulatory authorities and external partners
• Analyze existing processes, define improvement measures, and contribute to strategic quality system development

What sets you apart: