Senior Quality Lead: Quality Assurance / GxP audits / audit management / GCP / GVP / IVD/MD /Clinical Operations / Stakeholder Management / English / German Background: The Senior Quality Lead is an experienced Quality Professional who supports the Roche/Genentech Organization through the development and delivery of Quality Assurance strategies, audits, and conclusions for various entities (e.g., molecules in development, post-approval products, affiliates, processes, programs). This role ensures effective implementation of Quality Assurance to stakeholders and Health Authorities by generating evidence and actionable data through complex audits and quality activities. The perfect candidate possesses extensive experience within the pharmaceutical, biotechnology, or medical device industries, including comprehensive knowledge of product development lifecycles and relevant GxP regulations, such as GCP, GVP, and IVD/MD. They should demonstrate at least five years of experience leading GxP audits and managing complex quality projects, complemented by a deep understanding of drug development processes and global regulatory landscapes. Proficiency in information systems-specifically regarding audit management and analysis reporting tools-is required, as is prior experience in clinical operations or quality functions related to system validations.
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.
