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Quality Manager, CAPA - Carlsbad, CA (344923BR)





Carlsbad, California, United States

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. <br><br>JOB PURPOSE & IMPACT:<br>This position is responsible for managing the Navigate BioPharma CAPA program and assuring compliance with sponsor requirements, internal procedures and state and federal regulations as applicable for a bioanalytical laboratory supporting clinical trial/in vitro diagnostic development/nonclinical testing. The focus of this position includes but is not limited to managing the CAPA program, including issues and audit findings in compliance with applicable Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations and Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), ISO 15189 guidances, as applicable. <br><br>Location: Candidates must reside within driving distance to Carlsbad, CA to be considered. This role is not eligible for sponsorship.<br><br>ESSENTIAL DUTIES AND RESPONSIBILITIES:<br>• Manage CAPA/Issue program to ensure compliance with internal procedures and applicable regulations. Evaluate and provide guidance on risk assessment and impact for quality events (deviations, CAPAs, complaints, audit findings)<br>• Participate in internal audits and support sponsor and regulatory audits <br>• Analyze quality-related data, identify issues or trends, and make recommendations to management<br>• Support Quality activities and provide Quality oversight within CLIA/biopharma laboratory to ensure compliance for specimen testing to applicable GCLP/GCP/GLP requirements and applicable regulations<br>• Develop and monitor quality improvement initiatives and quality metrics in the laboratory<br>• Perform quality review and approval of laboratory procedures, technical protocols/reports and testing records<br>• As a member of the Quality Department, support other departmental activities as assigned with the main responsibility of oversight of the CAPA program<br><br><br>[#video#{#400,300#}#/video#]