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AstraZeneca
AstraZeneca
Sponzor vizuma H1BBiotehnologijaFarmacevtski izdelkiZdravstveno varstvo
AstraZeneca je znanstveno usmerjeno biofarmacevtsko podjetje, ki razvija in trži zdravila na recept za obravnavo najpomembnejših zdravstvenih izzivov. Njeno delo zajema onkologijo, srčno-žilne, ledvične in presnovne bolezni ter bolezni dihal, pri čemer združuje farmacevtske raziskave z razvojem in globalno dostopnostjo zdravljenja. AstraZeneca posluje v več kot 100 državah ter povezuje ekipe, usmerjene v napredek zdravljenja in izboljšanje izidov za bolnike po vsem svetu.
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Delovna mesta v podjetju

Senior Digital Business Process Product Lead

Lead digital products that modernize AstraZeneca’s regulated cell therapy operations, connecting planning, manufacturing, laboratory, quality, and supply chain systems.

USZdružene države AmerikeMDMaryland
124.000 $ – 185.000 $ / leto
Na lokacijiPolni delovni časSeniorZahtevani Jezik: angleščinaPoslovne operacije
ERP

Opis

  • Set product direction, roadmaps, and priorities for digital and business systems.
  • Oversee backlogs, requirements, user stories, acceptance criteria, dependencies, and delivery priorities.
  • Weigh business value and regulatory obligations against technical dependencies, operational risks, and available capacity.
  • Monitor benefits and measures such as planning accuracy, schedule adherence, cycle time, lab turnaround, batch review time, data quality, exceptions, and user adoption.
  • Guide end-to-end process design and improvement across planning, procurement, manufacturing, labs, quality, inventory, release, supply chain, and logistics.
  • Align processes across sites while accommodating justified local requirements.
  • Turn stakeholder needs into target processes, requirements, system designs, and digital capabilities.
  • Map processes, system interactions, information flows, roles, controls, and governance.
  • Lead business process and product work for OMP, SAP, PAS-X, Tulip, LIMS, OneLab, MODA, and related platforms.
  • Build data and AI capabilities into processes to support scale and productivity.
  • Partner strategically with Operations, Manufacturing, Quality, Laboratory, Supply Chain, Planning, and site leaders on digital initiatives.
  • Run workshops and governance meetings to align stakeholders on priorities, scope, process design, and implementation plans.
  • Direct cross-functional Agile teams from discovery and design through configuration, development, testing, validation, deployment, hypercare, and support handover.
  • Coordinate risks, dependencies, resources, release timing, operational readiness, communications, training, SOP updates, and adoption.
  • Present recommendations, investment needs, risks, roadmap decisions, and expected benefits to senior leaders.
  • Oversee relationships 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 cut manual work, improve data capture, reduce errors, and speed decisions.
  • Prepare processes and systems for future AI and machine learning use cases with suitable governance and human oversight.
  • Keep systems and processes aligned with GxP, AstraZeneca policies, data integrity principles, and regulatory expectations.
  • Work with Quality, Validation, and IT on risk-based computerized system assurance.
  • Apply requirements for 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 for audits and inspections.

Zahteve

  • Bachelor’s degree in engineering, computer science, information systems, life sciences, supply chain, business, or a related field.
  • At least 10 years in digital product or process management, enterprise or manufacturing systems, laboratory systems, supply chain technology, or a related area within a regulated industry.
  • At least three years leading product, process, solution, or digital business work to deliver capabilities in a regulated setting.
  • 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 understanding of manufacturing, laboratory, quality, planning, supply chain, and site operations.
  • Experience integrating 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 abilities.
  • 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 another complex manufacturing environment.
  • 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 in global, multi-site organizations and managing technology vendors or systems integrators.

Ugodnosti

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

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