Seher Lale Ayanoglu | Senior Director Quality North & East Europe and TMEA
Amgen

Lale Ayanoglu is a dedicated quality management professional with over two decades of experience in the pharmaceutical and biotechnology industries. In her role as the International Distribution Quality Senior Director at Amgen, she oversees quality operations across North and East Europe, Turkey, the Middle East, and Africa (TMEA). Her responsibilities include regulatory compliance and quality assurance for complex international distribution networks, as well as providing consistent support to both regional and local teams. Earlier in her career, Lale developed her structured approach to quality through hands-on experience in laboratory settings, including analytical testing, laboratory management, and validation processes. She successfully led laboratory validations and analytical method enhancements, contributing to improved accuracy and efficiency. This experience deepened her understanding of laboratory quality standards and solidified her commitment to precision and compliance. Prior to her current role, Lale served as Director of Quality at Amgen in Shanghai, China. In this capacity, she established quality frameworks aligned with international regulatory standards, effectively enhancing compliance and addressing complex distribution challenges. Lale is actively involved in compassionate use products and early access programs, emphasizing her commitment to patient-focused care by facilitating timely access to important therapies. Her balanced approach integrates proven traditional practices with innovative improvements, promoting continuous growth and excellence. Recognized for her strategic vision and collaborative leadership, Lale consistently navigates diverse regulatory environments effectively. She remains committed to maintaining high quality standards, prioritizing patient safety, and supporting operational excellence across all the regions under her guidance.