Senior Manager, Npi Quality Engineering

Johnson & Johnson Johnson & Johnson · Pharma · Groningen, Netherlands

Senior Manager, New Product Introduction (NPI) Quality Engineer at Johnson & Johnson in Groningen, Netherlands. This role leads the NPQE function within R&D, overseeing quality systems and compliance for new product introductions. Responsibilities include ensuring adherence to design controls, validation, and risk management, managing a team, and ensuring compliance with global regulations (FDA, ISO 13485, EU MDR). The role requires a Bachelor's degree, 8-10 years of industry experience, and 5 years of managerial experience. A key requirement is demonstrating an understanding of AI concepts, ethical AI practices, and prompt generation for efficiency.

What you'd actually do

  1. Lead and manage multiple New Product Introduction (NPI) projects across platforms.
  2. Provide guidance and training on quality systems and development processes.
  3. Develop and improve quality systems and validation programs.
  4. Monitor quality program effectiveness and drive continuous improvement.
  5. Manage and develop team members and ensure accountability.

Skills

Required

  • New Product Development
  • Quality Control (QC)
  • Quality Validation
  • FDA and international regulatory requirements
  • design controls
  • validation
  • risk management
  • leadership and team management skills
  • communication and interpersonal skills
  • analytical and problem-solving abilities
  • Microsoft Office tools
  • AI concepts and frameworks
  • responsible and ethical AI practices
  • generating effective prompts

Nice to have

  • Business Alignment
  • Collaboration
  • Compliance Management
  • Fact-Based Decision Making
  • Good Manufacturing Practices (GMP)
  • ISO 9001
  • Mentorship
  • Organizing
  • Quality Auditing
  • Quality Management Systems (QMS)
  • Quality Standards
  • Regulatory Environment
  • Standard Operating Procedure (SOP)
  • Tactical Thinking
  • Technical Credibility

What the JD emphasized

  • Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity