Dot Compliance
Dot Compliance
„Dot Compliance“ kuria dirbtiniu intelektu grindžiamas elektronines kokybės valdymo sistemas gyvybės mokslų organizacijoms, įskaitant farmacijos, biotechnologijų ir medicinos prietaisų įmones. Jos platforma padeda kokybės komandoms vienoje aplinkoje valdyti dokumentaciją, pokyčius, rizikas ir atitikties procesus, o kokybės duomenis paversti praktinėmis įžvalgomis. Supaprastindama reglamentuojamus procesus, „Dot Compliance“ padeda organizacijoms išlaikyti atitiktį teisės aktų reikalavimams ir kartu plėtoti naujus produktus bei veiklą.

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.

Aprašymas

  • 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.

Reikalavimai

  • 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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