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AstraZeneca
AstraZeneca
Sponsor pentru viza H1BAsistență medicalăBiotehnologieProduse farmaceutice
AstraZeneca este o companie biofarmaceutică orientată spre știință, care dezvoltă și comercializează medicamente eliberate pe bază de prescripție pentru provocări majore din domeniul sănătății. Activitatea sa acoperă oncologia, afecțiunile cardiovasculare, renale și metabolice, precum și bolile respiratorii, îmbinând cercetarea farmaceutică cu dezvoltarea și furnizarea globală a tratamentelor. Cu operațiuni în peste 100 de țări, AstraZeneca reunește echipe concentrate pe avansarea tratamentelor și îmbunătățirea rezultatelor pentru pacienții din întreaga lume.
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Locurile de muncă ale companiei

Senior Digital Business Process and Product Lead

Lead digital products and regulated business systems supporting AstraZeneca’s cell therapy operations. Shape process roadmaps, integrations, analytics, compliance, and cross-functional delivery.

USStatele Unite ale AmericiiMDMaryland
124.000 $ – 185.000 $ / an
La sediuNormă întreagăSeniorLimbă Obligatorie: englezăOperațiuni de afaceri
ERP

Descriere

  • Set product vision, strategy, roadmaps, and priorities across digital and business systems.
  • Oversee backlogs, requirements, user stories, acceptance criteria, dependencies, and delivery priorities.
  • Measure benefits and performance across planning accuracy, schedule adherence, cycle time, lab turnaround, batch review duration, data quality, exceptions, and user adoption.
  • Lead end-to-end process design and improvement across planning, procurement, manufacturing, laboratories, quality, inventory, release, supply chain, and logistics.
  • Align processes across sites while accommodating justified local requirements.
  • Turn stakeholder needs into future-state processes, requirements, system designs, and digital capabilities.
  • Map processes, system interactions, information flows, roles, controls, and governance.
  • Guide business processes and products across OMP, SAP, PAS-X, Tulip, LIMS, OneLab, MODA, and related platforms.
  • Oversee interfaces, data flows, releases, upgrades, incidents, remediation, platform performance, and decommissioning.
  • Integrate data and AI capabilities into business processes to support scale and productivity.
  • Act as a strategic digital partner to Operations, Manufacturing, Quality, Laboratory, Supply Chain, Planning, and site leaders.
  • Run workshops and governance forums to align stakeholders on priorities, scope, process design, and implementation plans.
  • Lead cross-functional Agile teams from discovery and design through configuration, development, testing, validation, deployment, hypercare, and support handover.
  • Coordinate risks, dependencies, resources, release sequencing, operational readiness, communications, training, SOP updates, and adoption.
  • Present recommendations, investment requirements, risks, roadmap decisions, and expected benefits to senior leaders.
  • Manage partnerships with software vendors, implementation partners, and systems integrators.
  • Work with Data & AI and IT teams to improve master and transactional data, metadata, lineage, ownership, and access controls.
  • Support reporting, operational analytics, predictive insights, planning optimization, and performance management.
  • Find automation opportunities that reduce manual work and errors, improve data capture, and speed decisions.
  • Prepare processes and systems for future AI and machine learning applications with appropriate governance and human oversight.
  • Keep systems and processes aligned with GxP, AstraZeneca policies, data integrity principles, and regulatory expectations.
  • Partner with Quality, Validation, and IT on risk-based computerized system assurance.
  • Apply controls for ALCOA+, audit trails, electronic records and signatures, 21 CFR Part 11, EU GMP Annex 11, access, segregation of duties, traceability, and change control.
  • Maintain documentation, test evidence, decision records, process controls, and lifecycle records for audits and inspections.

Cerințe

  • Bachelor’s degree in engineering, computer science, information systems, life sciences, supply chain, business, or a related field.
  • At least 10 years of experience in digital product or business process management, enterprise or manufacturing systems, laboratory systems, supply chain technology, or a related area in a regulated industry.
  • At least 3 years leading products, processes, solutions, or digital business initiatives that deliver digital capabilities in regulated settings.
  • Experience with several platforms or technologies such as OMP, SAP, PAS-X, Tulip, LIMS, OneLab, MODA, ERP, MES, electronic batch records, quality or planning systems, workflow platforms, or data historians.
  • Strong understanding of manufacturing, laboratory, quality, planning, supply chain, and site operations.
  • Experience connecting operational systems with enterprise platforms, data platforms, analytics solutions, and digital products.
  • Track record 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.
  • Hands-on experience with at least two 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 tools, 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.
  • Certification in Agile, Scrum, Product Management, Lean Six Sigma, or a related discipline.
  • Experience working across global, multi-site organizations and managing technology vendors or systems integrators.

Beneficii

  • May qualify for short-term incentive bonuses.
  • Equity awards are available for salaried roles.
  • Qualified retirement programs.
  • Paid vacation, holidays, and leave.
  • Health coverage.
  • Dental coverage.
  • Vision coverage.
  • Accommodation support for applicants with disabilities or special needs.

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