Director Global Quality Systems & Compliance (m|f|d)

As Senior Manager, you will lead the global Quality Management System and regulatory compliance across pharma, medical devices, and ISO-regulated activities. You enable cross-functional alignment between regulatory expectations and business processes to support sustainable performance and continuous improvement. You will oversee CSV, IT workflows, and governance of QA processes, while driving audits, KPIs, and QMR/APQR activities. This role offers a strategic, global impact in a mission to advance biomedical innovation.

• diversity: international teams and intercultural communication
• room for creativity
• health & sport: corporate sports and health provisions
• Miltenyi University: in-house training academy

• Develop, maintain and continuously improve a global QMS meeting Global GxP, MDR, ISO requirements
• Provide QA oversight for Computer System Validation (CSV) and IT workflows, including digital/AI-enabled solutions from quality perspective
• Govern global quality processes: Document Management, Training Management, Deviation Management, CAPA, Change Control, QRM
• Lead and coordinate global Quality Compliance activities: internal/external audits, third-party qualification/oversight, product complaints, recalls
• Define, trend and report Quality KPIs; lead Quality Management Reviews (QMRs) and support APQRs
• Act as strategic quality partner to senior stakeholders, ensuring embedding of quality culture across the organization
• Navigate regulatory complexity pragmatically to align quality systems with business objectives
• Lead teams and collaborate with external customers across cultures (English and German)

• Academic degree in a scientific or technical discipline or vocational qualification with relevant QA/Quality Assurance experience in regulated pharma environments
• Extensive experience in Quality Assurance, Quality Governance and Quality Systems in Pharma/Biotech and potentially Medical Devices
• Strong knowledge of global GxP regulatory requirements (FDA, EMA, ICH, MDR, ISO 13485, 9001, 21CFR820)
• Proven track record of building/maintaining global QMS including quality processes and IT workflows
• Experience leading or participating in Health Authority inspections and customer audits
• Experience leading quality compliance activities including auditing, KPIs and QMRs
• Experience leading teams and collaborating with external customers across cultures; fluency in English and German
• Analytical, structured thinking with a pragmatic, collaborative leadership style

• Leadership
• Strategic thinking
• Cross-cultural collaboration
• Quality Management System (QMS) leadership
• Computer System Validation (CSV) oversight
• Quality processes: Document Management, Training Management, Deviation, CAPA, Change Control, QRM