Regulatory Process Excellence Lead – RA Issue & CAPA

Regulatory Jobs; North Chicago (IL); Hybrid; USD 120,000 - 160,000; Full time

Job summary

AbbVie is seeking a Senior Manager, Process Excellence within Regulatory Affairs to lead key process improvements and issue management initiatives. You will oversee the RAIM system, triage and escalate issues, and partner across functions to drive compliance and efficiency.

The role supports inspection readiness, change management for legacy integrations, and governance-aligned documentation. The position operates on a hybrid schedule from Lake County, IL.

Qualifications

• Required education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
• Required Experience: 8+ years of regulatory, pharmaceutical or device experience.
• Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred.
• Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows.
• Experience supporting audit and inspection readiness in a regulated environment.

Responsibilities

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are logged, assessed, tracked, and resolved.
• Triage RAIM issue records to determine severity, impact, and next steps.
• Escalate issue records to Exception Reports when needed based on risk or process significance.
• Project manage Exception Reports with cross-functional stakeholders to identify root causes and drive corrective actions.
• Collaborate with Regulatory Affairs leaders and other functions to ensure timely, coordinated issue management.
• May support audits and inspections, including documentation coordination and response support.
• Manage legacy integrations for Regulatory Affairs processes through change plans in OneTrack.
• Ensure process documentation and change plans align with governance expectations.
• Communicate effectively with stakeholders to implement and adopt process changes.
• Hybrid work schedule (3 days in office, 2 days remote) from Lake County, IL headquarters.

Skills

Regulatory affairs

Process excellence

Issue management

CAPA

Audit readiness

Project management

Cross-functional collaboration

stakeholder management

Education

Bachelor's degree in life sciences

Advanced degree in science or business (preferred)

Job description

AbbVie is seeking a Senior Manager, Process Excellence within Regulatory Affairs to lead key process improvements and issue management initiatives. You will oversee the RAIM system, triage and escalate issues, and partner across functions to drive compliance and efficiency.

The role supports inspection readiness, change management for legacy integrations, and governance-aligned documentation. The position operates on a hybrid schedule from Lake County, IL.