James Powers

Background

About James Powers

Quality, compliance and lean leader with over 30 years of biotech, pharmaceutical, cell and gene therapy, aseptic, vaccine, generic, API and personal care companies. A passion for improving quality and laboratory operations across different industry segments from API to cell and gene therapy work environments. A change leader who helps win the hearts and minds of people in the process. Professional experience experience includes proactive leadership, designer and implementer of compliance / GMP based solutions across global businesses including laboratory excellence, quality culture, deviation management, CAPA, change control and notification to management. Specific leadership experience in directing site based and global solutions for quality, laboratory and compliance operations. Practical working experience in pharmaceutical, cell and gene therapy, biotech, aseptic, vaccine, generic, API and personal care companies. Direct experience in working with boards of health including the FDA. Experienced with leading Warning Letters and Consent Decree responses and remediation efforts. Experience includes hands on leadership of Data Integrity assessments, remediation, strategy development and risk assessments in response to regulatory inspections for both small and global pharmaceutical, biotech and personal health care organizations. Expertise includes performing detailed assessments of chromatography data systems (CDS) including electronic records, supporting audit trails and user roles. Developing interim measures that can be taken to protect patients and to ensure the quality of drug products. Developing long-term remediation strategies and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources to ensure data integrity. James has helped clients design and implement company wide Data Integrity programs. Chair the ASTM E1578 Standard Laboratory Informatics Guide – Work Group responsible for developing and updating the open ASTM international standard on Laboratory Informatics.