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8 дней назад

Specialist, Process & Data Management (PDM) Program Expert (AI)

60 000 - 96 255€
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
UK/US/Netherlands +2 еще
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
Specialist, Process & Data Management (PDM) Program Expert (AI): Developing compliant quality processes, training materials, and qualification solutions for global R&D organizations with an accent on regulatory integration, GxP quality systems, and data-centric content management. Focus on mapping evolving requirements, coordinating cross-functional implementation, and managing change, risks, CAPAs, inspections, and qualification initiatives.

Location: Hybrid role available in Belgium, the Netherlands, Switzerland, the UK, or the US. Primary locations include Beerse and Antwerp, Belgium, and Breda, Netherlands.

Salary: €60,000–€96,255 annually in the primary posting location; Netherlands range: €53,500–€85,445 annually.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions as part of Johnson & Johnson’s broader healthcare organization.

What you will do

  • Lead and contribute to Adopting Regulatory Requirements and Quality Framework Integration initiatives.
  • Assess, design, implement, and integrate compliant end-to-end processes across the Quality Management System.
  • Develop and maintain GxP training, qualification, and process materials.
  • Coordinate content management and qualification transformation initiatives, including Aris CCL programs.
  • Support changes, CAPAs, inspections, investigations, regulatory requests, risk management, and issue resolution.
  • Communicate project progress, timelines, risks, and resolutions to business owners and management while collaborating across R&D Quality, Clinical Development, Medical Safety, and Regulatory Affairs.

Requirements

  • Bachelor’s degree in Science, Business, or a related field.
  • 1–3 years of experience in a medium-to-large matrix organization.
  • At least one year of experience in pharmaceutical, medical device, healthcare, compliance, or related R&D environments.
  • At least one year of experience in process design, training design, qualification management, or a related field.
  • Knowledge of global pre-clinical and clinical compliance regulations, life sciences requirements, process improvement, and qualification activities.
  • Proficiency with Microsoft Office, project management tools, process mapping concepts, and awareness of AI concepts, responsible AI practices, and effective prompting techniques.

Nice to have

  • Experience with process mapping or value stream mapping tools.
  • Experience with content management, qualification transformation, or data-centric quality initiatives.

Culture & Benefits

  • Collaborative work across global R&D Quality and healthcare functions.
  • Opportunities for learning, innovation, professional development, and process excellence.
  • Annual performance-based bonus or sales commission, depending on role and location.
  • Vacation, parental, bereavement, caregiver, and volunteer leave.
  • Well-being reimbursement, health programs, insurance plans, and recognition awards.

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