Associate Director, Digital & Business Process Strategy
Listed on 2026-07-04
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IT/Tech
IT Business Analyst, IT Project Manager, Data Analyst, Data Engineering
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 Chainand 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.
1. Product vision and roadmap
Define and socialize a compelling product vision linkingMES (PAS‑X, Tulip),Historian- CDZ, andLIMScapabilities to business outcomes (yield, cycle time, batch release, deviation reduction)
Build and manage amulti‑releaseroadmap, balancing global platforms with site needs, technical debt, and regulatory priorities.
Maintain a prioritized,value‑rankedbacklog with clear acceptance criteria and Definition of Done .
2. Stakeholder and value management
Act as the voice of Operations, Quality, and QA/QP in product decisions; translate pain points into epics/featuresto deliver e2e business processmaps andwell-defined business requirements
Quantify value through OKRs/KPIs (e.g., batch review time, exception rates, data availability SLAs) and track benefits realization.
3. Delivery leadership
Lead agile squads (process SMEs, solution architects, data engineers,MESconfiguration, historians, LIMS specialists, validation) to deliver increments.
Coordinate integration patterns betweenMES, historians, LIMS, ERP, data platforms, and analytics/AI products.
Ensure robust data models, master data stewardship, and event/transaction standards supporting traceability across systems.
4. 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.
5. 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 asreal‑timedeviation detection, golden batch, CPV/Continued Process Verification, ande /eBRRoptimization.
6. Operations readiness and lifecycle management
Plan releases, cutovers, and change management across multiple sites;coordinate training and SOP updates.
Own product performance, reliability, and cybersecurity posture; manage incidents, problem remediation, and continuous improvement.
Manage vendor relationships (e.g., Körber,Factory Talk,PAS‑X,Tulip, Historian and LIMS providers) and ensure contract deliverables align to roadmap.
Bachelor’s degree in engineering, life sciences, computer science, or related field; advanced degree preferred.
8+years in pharma/biotech or highly regulated manufacturing withhands‑onexposure to at least two of the following:
PAS‑X (or equivalent MES),process data historians (e.g., PI/AVEVA, IP.21, Ignition),LIMS/ELN.3+ years as a Product Owner or equivalent (product management, solution owner) delivering digital capabilities inGxPenvironments.
Strong understanding of manufacturing and quality processes: recipe management,e , batch disposition, deviation/CAPA, CPV, stability, and sample lifecycle.
Demonstrated experience integratingshop‑floorsystems with enterprise platforms (ERP, QMS) and data/analytics stacks; familiarity with ISA‑95/ISA‑88 models and data standards.
Practical knowledge of CSV/CSA, GAMP 5, data integrity, and audit expectations.
Experience with PAS‑X configuration and content management; knowledge of interface frameworks, E review workflows, and exception handling.
Background in OT/IT convergence: OPC UA, MQTT, edge connectivity,time‑seriesdata modeling, and event streaming.
Working knowledge of modern data platforms and analytics (e.g., cloud data lakes,time‑seriesservices, visualization, ML for manufacturing).
Certification in Agile/Scrum…
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