Melissa Schroeter serves as the Director of Quality Systems at the International AIDS Vaccine Initiative (IAVI), where she leverages her extensive expertise in drug development and regulatory compliance to drive innovative solutions in the biopharmaceutical sector. With a robust background that encompasses all phases of...
Melissa Schroeter serves as the Director of Quality Systems at the International AIDS Vaccine Initiative (IAVI), where she leverages her extensive expertise in drug development and regulatory compliance to drive innovative solutions in the biopharmaceutical sector. With a robust background that encompasses all phases of drug development, Melissa plays a pivotal role in ensuring that IAVI's projects adhere to stringent FDA regulations and Good Manufacturing Practices (GMP). Her legal acumen enhances her ability to liaise effectively with scientific teams, fostering a culture of compliance that is essential for maintaining the integrity of research and development efforts.
In her current role, Melissa is instrumental in the operational coordination of regulatory submissions for early-phase projects, guiding her team through the complexities of regulatory landscapes. Her experience in planning for inspections by government agencies and corporate audits ensures that IAVI is always prepared to meet the highest standards of quality and safety. Melissa's expertise in validation, change control, and the disposition of materials is critical in advancing IAVI's mission to develop effective vaccines against HIV and other infectious diseases.
Key projects under her leadership include the implementation of robust quality management systems that streamline processes and enhance efficiency, ultimately accelerating the path from research to clinical trials. With a strong focus on technology transfer and internal audits, Melissa is dedicated to fostering a culture of continuous improvement within the organization. Her multifaceted skill set, including knowledge of Good Laboratory Practices (GLP) and new product validation, positions her as a vital asset in the pursuit of groundbreaking advancements in the biopharmaceutical industry.
