ironquill.tech/board

$ cat jobs/director-qa-it-validation-venaris-executive-search-aps-96cecfa7b5ea.json

Director QA IT & Validation

venaris executive search aps·US·United States·mid
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As the new Director QA IT & Validation, you now have a unique opportunity to combine strategic leadership with hands-on quality oversight in an international, highly regulated environment where digitalization and business growth are high on the agenda. Lead QA IT & Validation across a global organization As Director QA IT & Validation, you will lead a team of three specialists and take overall responsibility for the quality oversight of GxP-regulated IT systems across the organization. Reporting to the EVP, Global Quality, you will be a key member of the Global Quality Management Team, shaping the QA IT strategy and ensuring compliance with global regulatory requirements. You will provide strategic leadership on IT quality, computerized system validation, data integrity, and quality governance while partnering closely with IT, Regulatory Affairs, Production, QC, and external vendors. You will play a pivotal role in major digital transformation initiatives, including the implementation of Veeva and a new ERP platform, ensuring quality and compliance are embedded throughout the system lifecycle. In addition, you will act as System Owner for the company's electronic Quality Management System (eQMS), oversee supplier audits and IT vendor qualifications, drive continuous improvement initiatives, and represent Quality in IT governance forums. Experienced QA IT Professional with proven leadership experience For this position, it is expected that you bring extensive experience within Quality Assurance and computerized system compliance in a regulated pharmaceutical or life sciences environment. You have in-depth knowledge of computerized system validation and are familiar with EU GMP, FDA requirements, and industry standards governing GxP-relevant IT systems, combined with practical experience supporting validation projects, quality management systems, and regulated IT environments. Finally, you possess a proven leadership/management capabilities coupled with a strategic mi