Digital Business Process, Product Lead – Digital and Business Systems

AstraZeneca

. Define the product vision, strategy, roadmap, and prioritization approach for a portfolio of digital and business systems .

Posted 10/11/2026full-timeRockville • Maryland • United StatesSenior💰 $124,000 - $185,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in digital product management and business process leadership within regulated environments, with a strong focus on integrating operational systems and enhancing data capabilities. Proficient in managing complex implementations and ensuring compliance with industry standards and regulations.

Highest-signal resume keywords

Digital Product ManagementBusiness Process ManagementGxP ComplianceStakeholder ManagementData Integration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process DesignRequirements ManagementAgile DeliveryOperational AnalyticsPerformance ManagementData Quality ImprovementAutomation IdentificationSystem EnhancementsChange ControlRisk Management

Soft Skills

FacilitationCommunicationInfluencingExecutive PresentationCollaboration

Tools & Technologies

OMPSAPPAS-XTulipLIMSOneLabMODAERPMESQuality Systems

Industry Keywords

Regulated IndustryManufacturing SystemsLaboratory SystemsSupply Chain TechnologyData Integrity21 CFR Part 11EU GMP Annex 11Audit TrailsCell TherapyPersonalized Medicine

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Define the product vision, strategy, roadmap, and prioritization approach for a portfolio of digital and business systems
Manage backlogs, requirements, user stories, acceptance criteria, dependencies, and delivery priorities
Balance business value, regulatory commitments, technical dependencies, operational risk, and available capacity
Track benefits and performance indicators including planning accuracy, schedule adherence, cycle time, laboratory turnaround, batch review duration, data quality, exception rates, and user adoption
Lead end-to-end process design and improvement across planning, procurement, manufacturing, labs, quality, inventory, release, supply chain, and logistics
Harmonize processes across sites while allowing justified local needs
Translate stakeholder needs into future-state processes, requirements, system designs, and digital capabilities
Define process maps, system interactions, information flows, roles, controls, and governance
Provide business process and product leadership for OMP, SAP, PAS-X, Tulip, LIMS, OneLab, MODA, and related platforms
Embed data and AI capabilities into business processes to accelerate scaling and maximize productivity
Serve as a strategic digital partner to Operations, Manufacturing, Quality, Laboratory, Supply Chain, Planning, and site leadership
Facilitate workshops and governance forums to align stakeholders on priorities, scope, process design, and implementation plans
Lead cross-functional Agile delivery teams through discovery, design, configuration, development, testing, validation, deployment, hypercare, and support transition
Manage risks, dependencies, resources, release sequencing, operational readiness, communications, training, SOP updates, and adoption
Present recommendations, investment needs, risks, roadmap decisions, and benefits to senior leaders
Manage relationships with software vendors, implementation partners, and systems integrators
Improve master data, transactional data, metadata, lineage, ownership, and access controls with Data & AI and IT teams
Enable reporting, operational analytics, predictive insights, planning optimization, and performance management
Identify automation opportunities to reduce manual effort, improve data capture, reduce errors, and accelerate decision-making
Ensure processes and systems support future AI and machine learning use cases with appropriate governance and human oversight
Ensure systems and processes comply with GxP, AstraZeneca policies, data integrity principles, and regulatory expectations
Partner with Quality, Validation, and IT teams on risk-based computerized system assurance
Apply requirements related to ALCOA+, audit trails, electronic records and signatures, 21 CFR Part 11, EU GMP Annex 11, access controls, segregation of duties, traceability, and change control
Maintain documentation, test evidence, decision records, process controls, and lifecycle records to support audits and inspections

Requirements

What you’ll need

Bachelor’s degree in engineering, computer science, information systems, life sciences, supply chain, business, or a related discipline
10+ years of experience in digital product management, business process management, enterprise systems, manufacturing systems, laboratory systems, supply chain technology, or a related field within a regulated industry
At least 3 years of product, process, solution, or digital business leadership experience delivering digital capabilities in a regulated environment
Experience with several platforms or technologies such as OMP, SAP, PAS-X, Tulip, LIMS, OneLab, MODA, ERP, MES, electronic batch records, quality systems, planning systems, workflow platforms, or data historians
Strong knowledge of manufacturing, laboratory, quality, planning, supply chain, and site operations
Experience integrating operational systems with enterprise platforms, data platforms, analytics solutions, and digital products
Proven experience leading complex implementations, releases, process transformations, or system enhancements
Practical knowledge of GxP, CSV/CSA, GAMP 5, data integrity, 21 CFR Part 11, EU GMP Annex 11, audit trails, electronic records, and change control
Strong stakeholder management, facilitation, communication, influencing, and executive presentation skills
Direct experience with two or more of OMP, SAP, PAS-X, Tulip, LIMS, OneLab, and QC systems
Experience in cell therapy, cell and gene therapy, personalized medicine, biologics, sterile manufacturing, or other complex manufacturing environments
Experience with MES, electronic batch records, connected worker technologies, laboratory execution, advanced planning, supply chain optimization, manufacturing intelligence, or operational analytics
Knowledge of OT/IT integration standards such as OPC UA, MQTT, ISA-88, ISA-95, edge connectivity, and event-driven architecture
Experience working across global, multi-site organizations and managing technology vendors or systems integrators

Benefits

Comp & perks

Eligibility for short-term incentive bonuses
Equity-based awards for salaried roles
Qualified retirement programs
Paid time off, including vacation, holiday, and leaves
Health coverage
Dental coverage
Vision coverage
Accommodation support for disabilities or special needs