Job Details

The Global Director, Quality Compliance supports the overall Lonza strategy to gain and maintain the license to operate. This is achieved by lowering the quality and compliance risk through audits, advising the sites to reach an optimum state of compliance. Develop, plan and execute a program of corporate GMP compliance audits/assessments for Lonzas manufacturing sites and operations with a focus on sterile and non-sterile drug products (including solid dosage forms, biologics, cell/gene therapy), biological and chemical APIs, medical devices and excipients. This also covers food, feed and dietary supplements and sites involved in software and hardware manufacture. Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Lonza expectations and requirements. Advise, guide and lead the support for sites in the preparation for, and overall management of, regulatory inspections. Provide expertise to sites and the global organization...Director, Compliance, Quality, Global, Operations, Auditor, Manufacturing, Technology