Director, Digital Quality & Intelligence

Role: The Director, Head of Digital Quality & Intelligence, leads strategic initiatives within Global Quality Management Systems to enhance quality oversight through data analytics, automation, and AI. Main objectives include shaping the digital quality strategy, translating business/regulatory needs into scalable digital solutions, and managing a global team of data scientists, analysts, and software developers. Responsibilities involve developing risk-based QMS strategies, overseeing portfolio execution, establishing governance for digital tools, and ensuring compliance with quality and regulatory standards. Qualifications: Bachelor's in a quantitative or life sciences field required; >10 years of industry experience in biopharma, diagnostics, or medical devices, with >5 years leading global teams in analytics, automation, and digital quality; proven project and portfolio management skills. Preferred skills include knowledge of QMS operations, regulatory compliance (FDA 21 CFR Part 11), and experience with analytics platforms, cloud environments, AI/machine learning, and related lifecycle management tools. High-value specifics involve digital transformation within regulated environments, AI/automation oversight, and QMS modernization across global biopharma functions. The role reports to the AVP of QMS, involves leadership of cross-functional teams, and requires occasional travel. The position is full-time, day shift, with a salary range of approximately $153K–$287K plus bonuses and benefits.