Trackwise Digital Support Lead

Job Position: Trackwise Digital Support Lead

Job Location: Center Valley, PA (Onsite)

Job Duration: Fulltime

Salary: $150K - $180K/Annum with benefits

Job Description:

Must Have Technical/Functional Skills:

• Strong relevant experience, including demonstrated L2/L3 support expertise for TrackWise / TrackWise Digital QMS in regulated life sciences or medical device environments.
• Hands-on expertise in TrackWise Digital support for global complaint handling, post-market support, complaints management and adverse event reporting processes.
• Good understanding of TrackWise configuration, Coordinator Configuration, workflow configuration, Team Access, Web Admin, PR Import / Selection Import, master data import and user access administration.
• Proven ability to troubleshoot record issues, stuck workflows, access issues, configuration defects, data issues, interface failures and recurring production defects within SLA.
• Strong technical knowledge of SQL, TrackWise database structure, Crystal Reports, data validation, root-cause analysis, change/problem management and stakeholder communication.
• Project Management, Team Management, Customer Interactions

Good To Have:

• Working knowledge of TrackWise Digital on Salesforce platform, including roles/profiles, permission sets, page layouts, reports, dashboards, SOQL queries, Data Loader and Import Wizard.
• Experience supporting interfaces between TrackWise Digital and global source systems through middleware platforms such as MuleSoft.
• Knowledge of GxP, 21 CFR Part 11, validated-system support practices, audit readiness and controlled change/release management.
• Basic awareness of Windows Server, application monitoring, service health checks and infrastructure coordination for support issue resolution.
• Experience with ITSM tools such as ServiceNow for incident, problem, change, SLA tracking, ticket review and continuous improvement.

Roles & Responsibilities:

• Serve as the Support Lead L2/L3 support contact for TrackWise Digital, restoring business-critical complaint handling and post-market quality services quickly and meeting agreed SLAs.
• Lead incident triage, impact assessment, escalation, stakeholder communication, root-cause analysis and post-incident corrective/preventive actions.
• Diagnose and resolve issues across TrackWise Digital records, workflows, access/security, configuration, reports, dashboards, interfaces and data layers.
• Support global complaint handling processes covering complaint record creation, complaints management, post-market support and adverse event reporting.
• Troubleshoot stuck records, workflow status issues, user access exceptions, master data import issues, PR Import / Selection Import issues and record lifecycle exceptions.
• Coordinate with MuleSoft / integration teams for failed transactions, source-system data mismatches, complaint record creation issues and interface monitoring.
• Prepare SQL queries, data analysis, validation evidence and reporting extracts required for ticket resolution, audit support and operational reviews.
• Participate in change, release, validation and deployment activities, maintaining required documentation and traceability for a regulated QMS environment.
• Collaborate with quality, regulatory, business process owners, integration, infrastructure, QA/validation and vendor teams to resolve production issues a nd deliver approved enhancements.
• Provide guidance to junior support analysts, maintain knowledge articles / troubleshooting guides, conduct ticket trend analysis and recommend continuous improvements.

Generic Managerial Skills, If any:

• Strong stakeholder communication, incident escalation, and cross-functional coordination.
• Ability to guide support teams, mentor junior members, and lead small enhancement workstreams.
• Ownership of SLA delivery, documentation quality, and continuous improvement