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Lead, Computer System Validation - T&DQ

Johnson & Johnson · Raritan, NJ +1 more

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QualityFull-time$94k–$152kCompany career page

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Role summary

Johnson & Johnson seeks a Lead for Computer System Validation within Technology & Digital Quality to oversee quality integration across enterprise systems throughout their lifecycle. The role involves managing validation activities, ensuring regulatory compliance, and guiding cross-functional teams in the Innovative Medicine segment.

What they're looking for

  • Expertise in computer system validation and GxP system compliance
  • Knowledge of software development lifecycle (SDLC) and quality assurance practices
  • Experience managing validation documentation and regulatory deliverables
  • Ability to lead and mentor teams in quality and compliance functions
  • Strong stakeholder management and cross-functional collaboration skills
  • Understanding of health authority inspection and audit requirements
  • Project management experience with quality operations initiatives

What you'll be doing

  • Oversee end-to-end quality processes for enterprise systems from design through retirement
  • Manage validation activities for GxP systems and approve SDLC documentation deliverables
  • Ensure early quality involvement in design and development with preventive controls
  • Provide compliance guidance and technical expertise to project teams and stakeholders
  • Support internal audits, regulatory inspections, and incident management activities

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