Sharlene Lugo

Sharlene Lugo is the Director of Quality Assurance at BioNTech SE, responsible for the setup and support of modular manufacturing BioNTainers at the global level. She has held a variety of technical positions within quality and manufacturing support functions during her 20 years of experience in the biopharmaceutical industry including leading the commissioning, qualification, and validation of facilities, utilities, equipment, and processes for commercial and clinical operations. As a proven Quality leader, Sharlene has been responsible for building, implementing, and maintaining global Quality Management Systems processes, leading global cross-functional team continuous improvement initiatives and site inspection readiness activities for a wide range of regulatory inspections. An ISPE member since 2010, Sharlene holds a BS in Microbiology from the University of Puerto Rico and is an American Society for Quality Certified Manager of Quality and Organizational Excellence.