Associate Director, Clinical QA & Audit Strategy

AbbVie; North Chicago (IL); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k)

Long-term incentives

Job summary

AbbVie seeks a senior Clinical Auditor leader to manage a cross-functional team across the Americas. You will steer the clinical audit program, align with RDQA policies, and advance the AbbVie Quality System by collaborating with business partners and other RDQA functions.

The role requires ensuring regulatory compliance, guiding audits, and driving continuous improvement across clinical development processes. Domestic/international travel is expected as part of leadership responsibilities.

Qualifications

• Leadership and team-building experience in regulated environments.
• Deep knowledge of quality systems and auditing standards.
• Broad understanding of worldwide clinical regulatory requirements and industry best practices.

Responsibilities

• Leads and develops a team of Clinical Auditors across the Americas.
• Supports development of the global Clinical Audit strategy at Americas level.
• Manages risk-based audit program and resolves non-compliances.
• Drives innovative quality strategies with partners across GxP RDQA.
• Supports implementation of quality systems and regulatory compliance initiatives.
• Analyses clinical development processes to assure quality and compliance.
• Provides strategic input to inspection support and participates in GCP inspections.
• Promotes ongoing education on quality guidelines for AbbVie staff.

Skills

Leadership

Auditing

Quality systems

Regulatory knowledge

Cross-functional teamwork

Communication

Education

Bachelor’s degree in science/health

Job description

AbbVie seeks a senior Clinical Auditor leader to manage a cross-functional team across the Americas. You will steer the clinical audit program, align with RDQA policies, and advance the AbbVie Quality System by collaborating with business partners and other RDQA functions.

The role requires ensuring regulatory compliance, guiding audits, and driving continuous improvement across clinical development processes. Domestic/international travel is expected as part of leadership responsibilities.