Associate Director, Digital & Business Process Strategy

Responsibilities

• ● The Associate Director, Digital & Business Process Strategy leads the vision, roadmap, and value delivery of digital products that span PAS X , Tulip (MES), data historians, and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business Process Strategy team and partners with Operations, Quality, Global IT, Data & AI, Supply Chain and Site teams to modernize data flows, improve Right First Time , and enable compliant, data driven decision making from shop floor to enterprise. You will be based in Rockville, MD and report to the Senior Director of Digital & Business Process Strategy. Key responsibilities
• ● Product vision and roadmap
• ● Define and socialize a compelling product vision linking MES (PAS X , Tulip ), Historian - CDZ , and LIMS capabilities to business outcomes (yield, cycle time, batch release, deviation reduction)
• ● Build and manage a multi release roadmap, balancing global platforms with site needs, technical debt, and regulatory priorities.
• ● Maintain a prioritized, value ranked backlog with clear acceptance criteria and Definition of Done .
• ● Stakeholder and value management
• ● Act as the voice of Operations, Quality, and QA/QP in product decisions; translate pain points into epics/features to deliver e2e business process maps and well-defined business requirements
• ● Quantify value through OKRs/KPIs (e.g., batch review time, exception rates, data availability SLAs) and track benefits realization.
• ● Delivery leadership
• ● Lead agile squads (process SMEs, solution architects, data engineers, MES configuration, historians, LIMS specialists, validation) to deliver increments.
• ● Coordinate integration patterns between MES , historians, LIMS, ERP, data platforms, and analytics/AI products.
• ● Ensure robust data models, master data stewardship, and event/transaction standards supporting traceability across systems.
• ● Compliance and validation
• ● Ensure products comply with GxP , 21 CFR Part 11/Annex 11, data integrity (ALCOA+), and site/enterprise validation requirements.
• ● Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit readiness.
• ● Data and analytics enablement
• ● Enable contextualized data capture and lineage from equipment and MES to historian and LIMS; expose governed data to analytics platforms.
• ● Partner with Data & AI teams on use cases such as real time deviation detection, golden batch, CPV/Continued Process Verification, and eBR / eBRR optimization.
• ● Operations readiness and lifecycle management
• ● Plan releases, cutovers, and change management across multiple sites; coordinate training and SOP updates.