Director, Digital Quality & Intelligence

Role: Senior leader overseeing digital quality and intelligence within Global Quality Management Systems, focusing on quality analytics, automation, AI, and digital transformation. Responsibilities: develop and execute a risk-based QMS strategy for global quality and regulatory functions, translating complex needs into scalable digital solutions; lead a global team of data scientists, analysts, and developers; establish governance and lifecycle controls for AI/automation tools; manage portfolio and cross-functional projects, ensuring alignment with regulatory standards and inspection readiness; promote adoption and responsible use of digital quality capabilities; monitor industry trends to inform strategy; advise GQ leadership on advanced data science and automation initiatives. Requirements: bachelor’s degree in a quantitative/scientific field; 10+ years in life sciences with managerial experience; 5+ years managing global teams in analytics, automation, or digital quality within biopharma, medical device, or diagnostics; proven experience in QMS, process harmonization, and regulated environments; strong portfolio and project management skills; working knowledge of analytics platforms, cloud environments, AI, and regulated data governance. Preferred: advanced degree, expertise in AI/machine learning, FDA 21 CFR Part 11, and experience with lifecycle management tools like Jira or Power Automate. HighValue: biopharma/regulatory, digital quality, AI, automation, GxP, global scope, cross-functional leadership, occasional travel, day shift, full-time. Reporting to AVP of QMS, leading a strategic, innovative, and compliance-driven digital quality organization.