Ulrike Baumgärtner is a senior consultant for quality strategy and founder of Passion4Quality, with over 25 years of leadership experience in the pharmaceutical industry. As a licensed pharmacist, she specializes in quality assurance, cleaning validation and the development of sustainable quality cultures.

During her time at Boehringer Ingelheim, she led the global Competence Center for Cleaning Validation, shaped corporate procedures, and presented cleaning validation concepts in numerous regulatory, FDA and customer inspections worldwide. Her work spanned the full lifecycle of cleaning validation – from risk assessment, sampling strategy and analytical method validation to protocol design, execution and hands-on swabbing and rinsing.

As a consultant, she has supported multiple clients in establishing robust cleaning validation concepts, including new API manufacturing facilities, solid dosage production sites and technology start-ups. She is known for bringing clarity to complex GMP environments and for bridging the gap between design assumptions and operational reality.