Director, Digital Quality & Intelligence

Role: Senior leadership of digital quality and intelligence within Global Quality Management Systems, focusing on integrating data, automation, AI, and digital strategies to enhance quality and regulatory processes. Responsibilities: develop and execute a risk-based QMS strategy across GQ and GRA; lead global teams of data scientists and developers; translate complex quality/regulatory issues into scalable digital solutions; establish governance, lifecycle controls, and delivery standards for analytics, automation, and AI; manage cross-functional portfolios, ensuring alignment with global quality frameworks and inspection readiness; champion responsible AI use and digital adoption; stay ahead of industry trends; serve as strategic advisor to senior leadership. Team Leadership: direct a global team, oversee talent development, and promote best practices in analytics, automation, and digital quality. Qualifications: bachelor’s degree in a STEM field; 10+ years in life sciences with managerial experience; 5+ years leading analytics, automation, or AI teams; strong knowledge of QMS, regulatory compliance, and digital tools; expertise in project management, portfolio planning, and stakeholder engagement. High-Value: experience with regulated quality operations, GxP and FDA considerations (e.g., 21 CFR Part 11), and AI applications such as machine learning and NLP within biopharma or medical device regulatory environments. Work Setup: full-time, on-site or hybrid, with occasional travel.