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AstraZeneca
AstraZeneca
H1B vīzas sponsorsBiotehnoloģijaFarmaceitiskie produktiVeselības aprūpe
AstraZeneca ir zinātnē balstīts biofarmācijas uzņēmums, kas izstrādā un komercializē recepšu zāles nozīmīgu veselības problēmu risināšanai. Tā darbība aptver onkoloģiju, sirds un asinsvadu, nieru un vielmaiņas slimības, kā arī elpceļu slimības, apvienojot farmācijas pētniecību, zāļu izstrādi un globālu pieejamību. AstraZeneca darbojas vairāk nekā 100 valstīs un apvieno komandas, kas koncentrējas uz ārstēšanas iespēju attīstīšanu un pacientu ārstēšanas rezultātu uzlabošanu visā pasaulē.
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Vakances uzņēmumā

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.

USAmerikas Savienotās ValstisMDMerilenda
124 000 $ – 185 000 $ / gads
KlātienēPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuUzņēmējdarbības operācijas
ERP

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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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