Robert Barner

Robert Barner serves as the Senior Director of Quality Assurance and Head of QA Operations at Amicus Therapeutics, where he plays a pivotal role in ensuring the highest standards of quality and compliance within the pharmaceutical industry. With extensive experience in Quality Management, Robert has successfully navigated the complexities of working with Contract Manufacturing Organizations (CMOs), where he has honed his skills in managing quality assurance processes, technical transfers, and the qualification and validation of facilities and equipment. His leadership is characterized by a commitment to building and developing high-performing teams, adept at both direct reporting and matrixed organizational structures.

At Amicus Therapeutics, Robert leads a dedicated team of quality validation, quality control, and quality assurance professionals, guiding them through the intricacies of batch disposition and regulatory compliance. His expertise in Good Manufacturing Practices (GMP) and familiarity with FDA regulations are instrumental in maintaining the integrity of clinical trials and ensuring that all products meet stringent quality standards. Robert is also skilled in process improvement initiatives, implementing Standard Operating Procedures (SOPs) and Corrective and Preventive Actions (CAPA) to enhance operational efficiency and mitigate risks.

Currently, Robert is spearheading key projects that focus on the enhancement of quality management systems, aiming to streamline processes and foster a culture of continuous improvement within the organization. His strategic vision and hands-on approach not only bolster the quality assurance framework at Amicus Therapeutics but also contribute significantly to the company's mission of delivering innovative therapies to patients in need. Through his leadership, Robert Barner exemplifies the critical role of quality assurance in the pharmaceutical landscape, ensuring that safety and efficacy remain at the forefront of product development and manufacturing.