Responsible for and manages the full AbbVie global supplier/TPM audit schedule, including supporting procedures, systems and planning. Additionally manages, provides strategy and support to audit planning team,

This includes being business system owner of onetrack for supplier/audit (as well as Soltraqs and GTW) IT system and ensuring the accuracy (records) and execution (function) of system vs process. This role owns the external audit process and procedures (including changes, process improvements and updates to procedures, process and systems) and leads the external audit Community of Practice (COP) quarterly updates to ensure alignment of process and potential improvement across the users.

Owner and team is responsible for process execution for managing system changes for 300-500 supplier changes (supplier additions, removals and record or system changes) annually.

Additionally, this leader and team is responsible for reporting on all external auditing metrics and performance as well as ownership for all Change Plans (CPs), exception events (ERs/NCRs), and Project Management/tracking of projects within the external auditing team.

Finally, this leader is the primary contact for all audit and inspection support for agency, internal and notified body audits related to external audits and audit process.   

Responsibilities

• BPO, system oversight and management for Onetrack auditing and supplier management module
  • Define SQM/supplier audit user requirements and drive system change/enhancements to ensure the system aligns with current business process from beginning to end. Collaborate with BTS to manage incident reporting and define appropriate corrective actions. Develop training materials and continuity planning.
  • This includes ensuring accuracy and maintenance of approximately 3800 quality relevant suppliers in the supplier auditing scope.
• Oversight of annual global external audit schedule (~ 400+ OSA, 200 global QQ, and 600 local QQ; approx. 800 changes a year with supplier removals, additions and updates) supporting approximately 3800 quality relevant suppliers/TPMs across Abbvie
  • Managing schedule, updates to plans and annual and global planning of external audit schedule. Opening and closing of scheduling including local low QQs
  • Ensuring audit prep, and audit support for all audits.
  • Team vets and manages all proposed changes and confirms expectations vs process and  support of the changes (CP)
• Team owns QMR-01-06-004 and supporting work instructions and tools for process and any changes.
  • Responsible to identify and support process and procedure improvement within audit and supplier management scope (help identify and eliminate pain-points through process improvement and procedure enhancements)
• Team owns quarterly auditing CoP and key contributor for Supplier CoE
• Team is responsible for all CPs, ERs, and Projects executed within audit team.
• Team is responsible for tracking training coordination needs within external auditing team
• SME and support for all audit and inspection requests for agency, notified body and customer audits for Abbvie for auditing
• Team is responsible for monthly reporting of all metrics
  • Includes tracking new suppliers added, removed and discontinued suppliers cleansed from auditQ and process execution (including CPs, ERs and projects)