Clinical QA Auditor — GCP & Compliance Expert

BioSpace; North Chicago (IL); On-site; USD 95,000 - 145,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Clinical Audit QA professional responsible for executing the clinical audit program, including scheduling, planning, reporting and resolution of CAPs, ensuring alignment with RDQA policies and worldwide GCP requirements.

You will support the AbbVie Quality System, provide guidance on GCP to business partners, lead audits (investigator sites, processes, systems, and affiliates), and contribute to continuous improvement and regulatory inspections.

Qualifications

• Bachelor’s degree in science or health-related field.
• 3-5 years in biopharma or with regulatory authority.
• 3-5 years in QA and/or Clinical Research Development.
• Strong analytical and data interpretation skills.
• Excellent communication and team collaboration.

Responsibilities

• Assure quality and compliance in a regulated environment across worldwide regulations and AbbVie policies.
• Lead and participate in Clinical Audit scheduling, planning and conduct activities.
• Communicate audit results clearly within target timeframes.
• Review and approve CAPs submitted in response to audit observations.
• Advance the AbbVie Quality System and support global quality assurance requirements.

Skills

Analytical skills

Interpersonal skills

Communication skills

Project management

Willingness to travel internationally

Education

Bachelor’s degree in science or health-related field

Job description

AbbVie is seeking a Clinical Audit QA professional responsible for executing the clinical audit program, including scheduling, planning, reporting and resolution of CAPs, ensuring alignment with RDQA policies and worldwide GCP requirements.

You will support the AbbVie Quality System, provide guidance on GCP to business partners, lead audits (investigator sites, processes, systems, and affiliates), and contribute to continuous improvement and regulatory inspections.