TrackWise QMS Consultant

Track Wise QMS Consultant

We are seeking an experienced Track Wise QMS Consultant to support our pharmaceutical client in New Jersey. The ideal candidate will have strong expertise in Track Wise configuration, implementation, and support, specifically within GxP-regulated environments. Responsibilities include:

• Implement and configure TrackWise Quality Management System modules.
• Collaborate with business users to gather requirements and translate into system functionality.
• Support validation activities (CSV) and documentation in compliance with FDA and GxP guidelines.
• Troubleshoot and resolve system issues, provide end-user training, and support audits.
• Work closely with QA, IT, and compliance teams to ensure QMS alignment with regulatory needs.

Requirements include:

• 5+ years of experience with TrackWise QMS (version 8 or higher preferred).
• Strong understanding of pharma/biotech quality processes (CAPA, Deviations, Audits, Change Control).
• Experience with Computer System Validation (CSV) and regulatory compliance (21 CFR Part 11, GAMP 5).
• Excellent communication and stakeholder management skills.
• Experience in integration with other enterprise systems (e.g., ERP, LIMS).
• Knowledge of cloud-based Track Wise Digital (optional depending on client).