Dr Stephan Krause, PhD, is currently Quality Director and PQL Team Leader in Development Quality, AstraZeneca Biologics. He is a results-driven leader with 20 years of technical, managerial, and executive experiences for quality and technical functions within global operations. He is a frequent conference presenter and author and has won multiple industry awards for his publications and leadership in improving industry best practices. Stephan was invited by FDA several times to present an industry perspective to the agency on relevant current topics. He is a member of PDA’s Board of Directors and is co-chair of AMTP Advisory Board and a member of the Advisory Board for Biopharmaceuticals and Regulatory Affairs/Quality.