Associate Director, Digital & Business Process Strategy

Role: Associate Director of Digital & Business Process Strategy leading the design and execution of digital solutions within AstraZeneca’s manufacturing, focusing on MES (PAS-X, Tulip), data historians, and LIMS to optimize data flow, compliance, and decision-making. Responsibilities include developing product vision and roadmaps, managing multi-release backlogs, stakeholder engagement, leading agile teams to deliver system integrations, ensuring GxP, 21 CFR Part 11 compliance, and validation strategies, and enabling advanced analytics integration. The role involves lifecycle management, vendor oversight, and coordinating changes across global sites. Qualifications: Bachelor’s degree in engineering, life sciences, or computer science; 8+ years in pharma/biotech manufacturing with hands-on experience in MES, Historians, or LIMS; at least 3 years as a Product Owner in GxP environments; strong knowledge of manufacturing and quality processes, GxP compliance, and systems integration. Preferred: experience with PAS-X configuration, OT/IT convergence, cloud data platforms, and agile certifications. Key skills include systems thinking, stakeholder influence, decision-making under regulatory constraints, and delivery management. The position is based in Rockville, MD, with responsibilities spanning digital product leadership, data integrity, and manufacturing process optimization in a regulated environment.