James Bridges
About James Bridges
Title: Director of Cell Therapy Quality
James Bridges holds the position of Director of Cell Therapy Quality. In this role, he oversees the quality assurance protocols and standards within the cell therapy sector. His responsibilities include ensuring compliance with regulatory standards, managing quality control processes, and implementing quality improvement strategies. His experience in this area plays a crucial role in maintaining the integrity and efficacy of cell therapy products.
Professional Certifications: Certified Quality Auditor and Biomedical Auditor
James Bridges has obtained multiple professional certifications, including Certified Quality Auditor and Certified Biomedical Auditor. These credentials highlight his expertise in auditing and quality assurance within the biomedical and pharmaceutical industries. These certifications are indicative of his ability to conduct thorough assessments of quality systems, ensuring adherence to established guidelines and standards.
Certified Six Sigma Green Belt
As a Certified Six Sigma Green Belt, James Bridges demonstrates proficiency in Six Sigma methodologies. This certification underscores his capability in employing data-driven approaches to improve processes and reduce variability in pharmaceutical and biological product manufacturing. His application of Six Sigma principles aids in enhancing operational efficiency and product quality.
Experience: 25 Years in Pharmaceutical and Biological Product Manufacturing
James Bridges brings 25 years of experience in pharmaceutical and biological product manufacturing to his current role. His extensive career has provided him with a deep understanding of production processes, quality control, and regulatory compliance. This long-standing experience equips him with the knowledge and skills necessary to navigate complex industry challenges.
Previous Roles in QA & QC Management
Throughout his career, James Bridges has held various roles in Quality Assurance (QA) and Quality Control (QC) management. These positions have enabled him to develop and refine quality systems, oversee compliance audits, and manage quality-related issues. His leadership in QA and QC functions ensures that products meet stringent quality standards.
Former FDA Investigator
Before his current role, James Bridges served as an FDA Investigator. In this capacity, he conducted inspections and investigations to ensure compliance with federal regulations governing pharmaceutical and biological products. His experience as an FDA Investigator provides him with a valuable perspective on regulatory requirements and enforcement practices.