Hybrid: Regulatory Affairs Process Excellence Lead

BioSpace; North Chicago (IL); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Senior Manager, Process Excellence within Regulatory Affairs to lead issue management, CAPA handling, and governance across legacy integrations. You will coordinate with Quality, Regulatory Leaders, and other functions to ensure inspection readiness and effective change management.

The role is based at our Lake County, IL headquarters with a hybrid work schedule. The ideal candidate has 8+ years in regulatory/pharma or device environments, strong organizational and

Qualifications

• Bachelor's degree in life sciences required.
• 8+ years of regulatory, pharmaceutical or device experience.
• Experience in issue/CAPA systems and audit readiness.

Responsibilities

• Manage RAIM to log, assess, track, and resolve issues.
• Triage RAIM records by severity and impact.
• Escalate records to Exception Reports as needed.
• Project manage Exception Reports with cross-functional teams.
• Collaborate with Regulatory Affairs and Quality to ensure timely issue management.
• Support audits and inspections and respond as needed.
• Lead change plans for legacy integrations in Regulatory Affairs.
• Maintain process documentation and change plans in governance alignment.
• Communicate and adopt process changes with stakeholders.
• Hybrid work schedule: 3 days in office, 2 days remote at Lake County, IL headquarters.

Skills

Regulatory affairs

CAPA management

Issue management

Stakeholder management

Audit support

Change management

Cross-functional collaboration

Documentation

Education

Bachelor's degree in life sciences

Tools

RAIM system

OneTrack

Job description

AbbVie is seeking a Senior Manager, Process Excellence within Regulatory Affairs to lead issue management, CAPA handling, and governance across legacy integrations. You will coordinate with Quality, Regulatory Leaders, and other functions to ensure inspection readiness and effective change management.

The role is based at our Lake County, IL headquarters with a hybrid work schedule. The ideal candidate has 8+ years in regulatory/pharma or device environments, strong organizational and