With over 20 years of experience in the life science industry, both in the EU and US, I am a seasoned IT compliance and quality management expert, currently serving as the Senior Director of Business Applications and IT Compliance at Alvotech, a leading biopharmaceutical company. In this role, I oversee the implementation and maintenance of a robust quality management system (QMS) and ensure the compliance of IT systems to GxP, GDPR, and safety risk management standards. I have a proven track record of delivering effective and efficient solutions that meet the needs and expectations of internal and external stakeholders, such as regulators, customers, and partners. I am also an active member and leader of several professional associations, such as ISPE and GAMP, where I share my knowledge and insights on best practices and emerging trends. I hold a master's degree in manufacturing systems engineering and a bachelor's degree in chemical engineering, as well as certifications in ISO/IEC 27001 Lead Auditor and Prosci Change Management. My mission is to leverage my skills and expertise to support the development and delivery of innovative and high-quality products that improve the lives of patients worldwide.