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Dot Compliance
Dot Compliance
51 – 200 Angajați
Sponsor pentru viza H1BAsistență medicalăBiotehnologieConsultanță
Dot Compliance dezvoltă sisteme electronice de management al calității, bazate pe inteligență artificială, pentru organizații din domeniul științelor vieții, inclusiv companii farmaceutice, de biotehnologie și producători de dispozitive medicale. Platforma sa ajută echipele de calitate să gestioneze documentația, modificările, riscurile și fluxurile de lucru privind conformitatea într-un singur mediu, transformând datele despre calitate în informații utile pentru acțiune. Prin simplificarea proceselor reglementate, Dot Compliance sprijină organizațiile care urmăresc să își mențină alinierea la cerințele de reglementare, în timp ce dezvoltă produse și operațiuni noi.
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Locurile de muncă ale companiei

Senior eQMS Implementation Consultant

Lead Dot Compliance eQMS implementations for life sciences customers, guiding digital quality transformation from planning through delivery. Train users and help ensure projects meet business and compliance objectives.

GBRegatul UnitRemoteNormă întreagăSeniorLiderLimbă Obligatorie: englezăConsultant
CloudPMP

Descriere

  • Guide life sciences customers through digital quality transformation.
  • Manage eQMS implementations from start to finish.
  • Advise customers on quality best practices.
  • Deliver projects that provide measurable value.
  • Lead customer implementations, managing scope, schedules, and quality goals.
  • Configure and improve Dot Compliance solutions to meet customer business and compliance needs.
  • Provide best practices and strategic guidance throughout each project.
  • Deliver training sessions, workshops, and ongoing coaching.
  • Develop and maintain project plans, schedules, estimates, and resource allocations.
  • Monitor progress, identify risks, and lead mitigation efforts.
  • Use AI tools to speed up project planning, configuration documentation, and training materials while ensuring accuracy, quality, and compliance.
  • Serve as a trusted advisor and build lasting customer relationships.

Cerințe

  • At least 7 years of experience in professional services, customer success, or project management in the life sciences sector.
  • Strong knowledge of regulatory requirements and quality processes in pharmaceuticals, biotechnology, or medical devices, including ISO 13485 and FDA 21 CFR Part 11.
  • Experience implementing eQMS platforms, preferably Salesforce-based systems.
  • Demonstrated ability to manage complex projects and lead cross-functional teams.
  • Bachelor’s degree in science, engineering, business administration, or a related field.
  • Excellent written and spoken English.
  • German or French is a plus.
  • Strong problem-solving, organizational, and stakeholder management skills.
  • Experience with Dot Compliance or comparable cloud-based QMS platforms is a bonus.
  • Familiarity with Salesforce CRM or the Force.com platform is a bonus.
  • PMP, PRINCE2, or an equivalent project management certification is a bonus.

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