Senior Manager, Regulatory Process Excellence (Hybrid)

ABBVIE; North Chicago (IL); Hybrid; USD 125.000 - 237.000; Vollzeit

Zusammenfassung

AbbVie is seeking a Senior Manager, Regulatory Affairs Process Excellence to lead issue management and CAPA activities, ensuring compliant, efficient, and inspection-ready Regulatory Affairs operations. The role oversees RAIM and partners with cross-functional teams to drive process improvements and change management.

The position requires 8+ years in regulatory/pharma or device roles, a life sciences degree, and the ability to influence in a matrixed environment.

Qualifikationen

• Bachelor's degree in life sciences required.
• 8+ years of regulatory, pharmaceutical or device experience.
• Experience managing issue/CAPA systems, exception reporting, or similar workflows.
• Experience supporting audit and inspection readiness in a regulated environment.
• Strong organizational, analytical, communication, facilitation, and stakeholder management skills.
• Ability to manage multiple priorities in a matrixed environment and influence without direct authority.

Aufgaben

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to log, assess, track, and resolve issues.
• Triage RAIM records to determine severity, impact, and next steps.
• Escalate issue records to Exception Reports based on risk, compliance impact, or process significance.
• Project manage Exception Reports with cross-functional stakeholders to drive corrective actions.
• Collaborate with Regulatory Affairs leaders, Quality, and other functions to ensure timely issue management.
• Provide support during internal and external audits and inspections.
• Manage legacy company integrations for Regulatory Affairs processes via change plans in OneTrack.
• Ensure documentation, issue records, and change plans align with governance expectations.

Kenntnisse

Stakeholder management

Analytical

Communication

Facilitation

Project management

Regulatory affairs

Process excellence

Ausbildung

Bachelor's degree in life sciences

Advanced degree preferred

Jobbeschreibung

AbbVie is seeking a Senior Manager, Regulatory Affairs Process Excellence to lead issue management and CAPA activities, ensuring compliant, efficient, and inspection-ready Regulatory Affairs operations. The role oversees RAIM and partners with cross-functional teams to drive process improvements and change management.

The position requires 8+ years in regulatory/pharma or device roles, a life sciences degree, and the ability to influence in a matrixed environment.