Regulatory Process Excellence Lead (Hybrid)

Skillcrush; Michigan; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits package

Long-term incentive programs

Job summary

AbbVie seeks a Senior Manager, Process Excellence in Regulatory Affairs to lead issue and CAPA management, ensure inspection readiness, and drive cross-functional process improvements across governance and change plans.

You will manage RAIM, coordinate with Quality, Business Process Owners, and others, support audits, and oversee legacy integrations into Regulatory Affairs processes, with a hybrid schedule (3 days in office, 2 remote) based in Lake County, IL.

Qualifications

• Bachelor's degree in life sciences required; advanced degree in science or business preferred; certification a plus.
• 8 years of regulatory, pharmaceutical or device experience required.
• Experience in Regulatory Affairs, Quality, process excellence, or related roles preferred.
• Experience managing issue/CAPA systems, exception reporting, or comparable 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 and work effectively across functions and levels.
• Ability to influence without direct authority in a matrixed 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 and process significance.
• Project manage Exception Reports with cross-functional stakeholders to identify root causes and corrective actions.
• Collaborate with Regulatory Affairs leaders, Quality, and other functions to ensure timely, well-coordinated issue management.
• Support audits and inspections, including documentation coordination and response support as needed.
• Manage legacy company integrations for Regulatory Affairs through change plans in OneTrack.
• Maintain process documentation, issue records, and change plans in alignment with governance.

Skills

Stakeholder management

Analytical skills

Communication skills

Facilitation

Project coordination

Change management

Education

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject)

Tools

RAIM

OneTrack

Job description

AbbVie seeks a Senior Manager, Process Excellence in Regulatory Affairs to lead issue and CAPA management, ensure inspection readiness, and drive cross-functional process improvements across governance and change plans.

You will manage RAIM, coordinate with Quality, Business Process Owners, and others, support audits, and oversee legacy integrations into Regulatory Affairs processes, with a hybrid schedule (3 days in office, 2 remote) based in Lake County, IL.