Marco Klinger

Marco Klinger is a senior quality and compliance professional with more than 15 years of experience across pharmaceutical, healthcare, and regulated industry environments. His work focuses on building and maintaining effective Quality Management Systems, GMP/GDP compliance, data integrity, validation, deviation management, and digital quality processes.

At Zamann Pharma Support GmbH, Marco has held senior Quality Assurance and quality leadership responsibilities since 2016. His experience includes implementing and maintaining Quality Management Systems aligned with ISO 9001, ISO 13485, ICH Q10, and GxP requirements, as well as developing SOPs, processes, guidelines, gap assessments, and risk-based quality controls.

A major part of Marco's work involves managing core pharmaceutical quality processes, including deviations, investigations, CAPA, change control, and data integrity based on ALCOA+ principles. He has also worked in specialist consulting roles covering non-conformity management, quality control, commercial quality, and regulatory compliance across different pharmaceutical organizations.

Marco also brings direct experience in nitrosamine risk and confirmatory testing projects. At Sanofi, he has supported project operations for nitrosamine confirmatory testing, combining project coordination with pharmaceutical quality and compliance requirements.

His core areas of expertise include:

• Quality Management Systems — ISO 9001 & ISO 13485
• GMP/GDP Compliance and Audit Readiness
• Deviation, Investigation, CAPA & Change Control
• Data Integrity and ALCOA+ Principles
• Computerized System Validation and Validation Management
• Digital Quality Systems — eQMS, eDMS & eLMS
• Nitrosamine Quality and Compliance Projects
• Medical Device Quality and Technical Documentation

Marco also holds professional qualifications in pharmaceutical validation, GMP fundamentals, documentation management, and SOP development, complementing his practical quality-management experience.

At Pharmuni, Marco brings this hands-on experience into learning and professional development, helping learners understand how GMP compliance, Quality Management Systems, deviations, CAPA, validation, and digital quality processes are applied in real regulated environments.