Senior Regulatory Process Excellence Lead (Hybrid)

AbbVie Inc.; North Chicago (IL); Hybrid; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Paid time off

401(k) plan

Medical/dental/vision insurance

Zusammenfassung

AbbVie Inc. is seeking a Senior Manager, Process Excellence within Regulatory Affairs.

This role oversees the RAIM system, triages issues, escalates as needed, and partners cross-functionally to drive process improvements for inspection-readiness and change management across legacy integrations. The position requires leading cross-functional collaboration, supporting audits, and ensuring governance-aligned documentation, with a hybrid schedule (3 days in office, 2 days remote) from Lake County,

Qualifikationen

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
• 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.
• Strong organizational, analytical, communication, facilitation, and stakeholder management skills.

Aufgaben

• 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, compliance impact, or process significance.
• Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes and drive corrective actions.
• Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely and effective.
• May provide support during internal and external audits and inspections, including coordination of documentation and response support.
• Manage multiple legacy company integrations for Regulatory Affairs processes through change plans in OneTrack.
• Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with governance expectations.
• Partner with stakeholders to support effective communication, implementation, and adoption of process changes.

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

AbbVie Inc. is seeking a Senior Manager, Process Excellence within Regulatory Affairs.

This role oversees the RAIM system, triages issues, escalates as needed, and partners cross-functionally to drive process improvements for inspection-readiness and change management across legacy integrations. The position requires leading cross-functional collaboration, supporting audits, and ensuring governance-aligned documentation, with a hybrid schedule (3 days in office, 2 days remote) from Lake County,