Digital Business Process & Product Lead - Digital and Business Systems

AstraZeneca is seeking an experienced Digital Business Process & Product Lead to shape and deliver digital capabilities that enable efficient, compliant, and data-driven operations across Cell Therapy Technical Operations. The role will lead business process and product strategy across platforms including OMP, SAP, PAS-X, TrakCell, Nexus, Tulip, LIMS, QMS, OneLab, MODA , and related planning, manufacturing, laboratory, quality, supply chain, workflow, and data systems.

Acting as the voice of Operations, Manufacturing, Quality, Supply Chain, Laboratory, and site stakeholders, you will translate business needs into scalable digital products, integrated processes, and prioritized roadmaps. You will partner with Global IT, Data & AI, Engineering, Quality, Validation, business teams, and technology vendors to deliver measurable improvements across the end-to-end value chain. You will be based in Rockville or Gaithersburg, MD and report to the Senior Director, Cell Therapy Tech Ops - Digital and Business Process Strategy.

Key responsibilities

• 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 such as 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.
• Use data, feedback, and metrics to drive continuous improvement.

Provide business process and product leadership for:

• OMP: Planning, scheduling, demand and capacity management, supply planning, and system integration.
• SAP: Materials, procurement, inventory, finance, manufacturing, quality, master data, and supply chain processes.
• PAS-X: Recipes, master batch records, electronic batch records, production execution, workflows, exception handling, and batch review.
• Tulip: Connected worker solutions, digital work instructions, training, standard work, and shop-floor data capture.
• LIMS and OneLab: Sample management, testing, results review, stability, laboratory operations, data integrity, and release activities.
• MODA and related platforms: Quality, manufacturing, laboratory, and operational workflows.
• Integration and lifecycle management: Interfaces, data flows, releases, upgrades, incidents, remediation, platform performance, and decommissioning.
• AI & Data Analytics – 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.

• Partner with Data & AI and IT teams to improve master data, transactional data, metadata, lineage, ownership, and access controls.
• Promote consistent data models, interfaces, identifiers, event standards, and business rules across platforms.
• Enable reporting, operational analytics, predictive insights, planning optimization, and performance management.
• Identify automation opportunities that reduce manual effort, improve data capture, reduce errors, and accelerate decision-making.
• Ensure processes and systems are structured to 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.

Required Qualifications

• Bachelor’s degree in engineering, computer science, information systems, life sciences, supply chain, business, or a related discipline; advanced degree preferred.
• 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.

Preferred Qualifications

• 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.
• Agile, Scrum, Product Management, Lean Six Sigma, or related certification.
• Experience working across global, multi-site organizations and managing technology vendors or systems integrators.

Key Competencies

• Digital product and portfolio leadership
• End-to-end business process expertise
• Enterprise and manufacturing systems thinking
• Business value and benefits realization
• Stakeholder influence and cross-functional collaboration
• Agile delivery, roadmap, and dependency management
• Compliance, validation, data integrity, and quality mindset
• Change leadership and user adoption
• Customer-focused process and product design

#CellTherapy

The annual base pay for this position ranges from $124K to $185K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.