Clinical Quality Audit Lead – RDQA & GCP Compliance

Regulatory Jobs; North Chicago (IL); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

401(k)

Job summary

AbbVie seeks a Clinical QA professional to drive the Clinical audit program, plan and report audits, and ensure alignment with RDQA policies. You will advise on GCP topics and support global QA activities across AbbVie's sites.

The role requires 3–5 years in biopharma QA or Clinical Research Development, strong analytical skills, and willingness to travel internationally, with a focus on regulatory compliance and continuous improvement.

Qualifications

• Bachelor’s degree in science (physical, life, health) or equivalent experience.
• 3-5 years in biopharmaceutical industry or with a regulatory authority.
• 3-5 years in Quality Assurance and/or Clinical Research Development.
• Strong analytical skills and ability to draw conclusions from data.
• Ability to work effectively with minimal supervision.
• High awareness of clinical trial regulations (ICH-GCP, EU Directive/Regulation).
• Willingness to travel internationally.

Responsibilities

• Assure quality and compliance in a regulated environment with worldwide regulations and AbbVie policies.
• Lead and participate in Clinical Audit scheduling, planning, and conduct to assess compliance.
• Communicate audit results clearly in writing and orally within target timeframes.
• Review and approve Corrective Action Plans and track actions to completion.
• Support development of Quality standards and the AbbVie Quality System for global QA requirements.
• Contribute to continuous improvement initiatives to ensure regulatory compliance.
• Participate in and support GCP inspections as required.
• Provide guidance on GCP regulations to RDQA and business partners.

Skills

Analytical skills

Communication

Project management

Team collaboration

Education

Bachelor’s degree in science

Job description

AbbVie seeks a Clinical QA professional to drive the Clinical audit program, plan and report audits, and ensure alignment with RDQA policies. You will advise on GCP topics and support global QA activities across AbbVie's sites.

The role requires 3–5 years in biopharma QA or Clinical Research Development, strong analytical skills, and willingness to travel internationally, with a focus on regulatory compliance and continuous improvement.