Global Clinical QA Auditor — GCP & Compliance

AbbVie Inc.; North Chicago (IL); Remote; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Paid time off

Medical/dental/vision insurance

401(k)

Zusammenfassung

AbbVie is seeking a Clinical QA Auditor to lead the execution of the Clinical audit program, including scheduling, planning and reporting to ensure global compliance with GCP and regulatory requirements. You will support RDQA, drive CAPs and participate in inspections, contributing to a robust quality system.

The role requires a Bachelor’s degree in a science or health field, 3–5 years in biopharma QA or clinical research, and the ability to travel internationally.

Qualifikationen

• Bachelor’s degree in science (physical, life, health) or healthcare profession 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 with data-driven conclusions.
• Ability to work independently in a dynamic environment.
• Knowledge of clinical trial regulations (ICH-GCP, EU directives).
• Willingness to travel internationally.

Aufgaben

• Assure quality and compliance in a regulated global environment through audit and QA oversight.
• Lead and participate in Clinical Audit scheduling, planning and conduct across sites, processes, systems and affiliates.
• Communicate audit results orally and in writing within target timeframes.
• Review and approve Corrective Action Plans and track actions to completion.
• Support development/maintenance of Quality standards for Clinical audit.
• 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.
• Promote education on quality and clinical guidelines for AbbVie staff.

Kenntnisse

Analytical skills

Project management

Communication

Independent work

GCP knowledge

Attention to detail

Ausbildung

Bachelor’s degree in science or health field

Jobbeschreibung

AbbVie is seeking a Clinical QA Auditor to lead the execution of the Clinical audit program, including scheduling, planning and reporting to ensure global compliance with GCP and regulatory requirements. You will support RDQA, drive CAPs and participate in inspections, contributing to a robust quality system.

The role requires a Bachelor’s degree in a science or health field, 3–5 years in biopharma QA or clinical research, and the ability to travel internationally.