Trackwise Managed Services Sr. Consultant

This role is for a Sr. Consultant focused on managed services for quality and compliance platforms like TrackWise, TrackWise Digital, and ComplianceWire. Responsibilities include system configuration, workflow development, user acceptance testing, integration solutions, GxP validation, ITSM ticket management, and platform administration. The role emphasizes leading delivery within quality and compliance workstreams and maintaining documentation.

What you'd actually do

  1. Lead and contribute to end-to-end delivery for TrackWise, TrackWise Digital, and ComplianceWire platforms — including requirements gathering, solution design, system configuration, workflow development, and user acceptance testing.
  2. Configure and administer quality management workflows including CAPA, deviation management, change control, audit management, complaint handling, and OOS/OOT investigations in TrackWise or TrackWise Digital.
  3. Design and implement compliance training curricula, learning paths, role-based assignments, and curriculum versioning within ComplianceWire or equivalent LMS platforms.
  4. Develop integration solutions connecting quality and compliance platforms with upstream and downstream systems (ERP, document management, LIMS), ensuring data integrity and regulatory traceability.
  5. Develop functional specifications, configuration workbooks, data migration plans, and GxP validation artefacts including IQ/OQ/PQ test scripts and traceability matrices.

Skills

Required

  • TrackWise
  • TrackWise Digital
  • ComplianceWire
  • LMS platforms
  • ITSM
  • ServiceNow
  • JIRA
  • ITIL
  • GxP
  • IQ/OQ/PQ
  • CAPA
  • deviation management
  • change control
  • audit management
  • complaint handling
  • OOS/OOT investigations
  • user access management
  • workflow and form configuration
  • integration monitoring
  • root cause analysis
  • incident management
  • problem management
  • change management
  • validation activities
  • go-live readiness
  • cutover planning
  • hypercare support
  • post-implementation review
  • team leadership
  • documentation
  • runbooks
  • SOPs
  • functional specifications
  • validation artefacts
  • change management records
  • Ability to work independently and collaborate as part of a team
  • Effective written and verbal communication skills
  • Meticulous attention to detail and quality of work product

What the JD emphasized

  • GxP validation artefacts
  • GxP requirements
  • GxP-compliant documentation