The Senior Manager, Process Excellence within Regulatory Affairs, is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.
Responsibilities:
- Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved
- Triage RAIM issue records to determine severity, impact, and appropriate next steps
- Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance
- Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve AbbVie processes
- Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effective
- May provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as needed
- Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack
- Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations
- Partner with stakeholders to support effective communication, implementation, and adoption of process changes.
- This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL AbbVie headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required