Global Clinical QA Auditor — RDQA & Compliance

Regulatory Jobs; Florham Park (NJ); Remote; USD 95,000 - 135,000; Full time

Benefits offered by this job

Paid time off (vacation, holidays, etc

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Clinical Audit Lead to execute the audit program, schedule, plan, report and resolve audits while ensuring adherence to RDQA policies. You will advise on GCP and quality topics for global business partners to ensure worldwide regulatory compliance.

You will contribute to the AbbVie Quality System, drive CAPA activities, and participate in inspections. Travel up to 40% is required to cover audits across sites and affiliates.

Qualifications

• Bachelor’s degree in science or healthcare field.
• 3–5 years in biopharmaceutical industry or regulatory authority.
• 3–5 years in Quality Assurance and/or Clinical Research Development.
• Strong analytical skills with data-driven conclusions.
• Willingness to travel internationally (up to 40%).

Responsibilities

• Assure quality and compliance in a regulated environment worldwide.
• Lead clinical audit scheduling, planning and conduct activities.
• Effectively communicate audit results, orally and in writing.
• Review and approve CAPAs and track actions to completion.
• Advance the AbbVie Quality System and support development of QA standards.
• Contribute to continuous improvement initiatives and inspections.
• Provide support on GCP regulations to RDQA partners.
• Promote education on quality and clinical guidelines.

Skills

Quality Assurance

Regulatory knowledge

GCP awareness

Audit coordination

Education

Bachelor’s degree in science or healthcare

Job description

AbbVie is seeking a Clinical Audit Lead to execute the audit program, schedule, plan, report and resolve audits while ensuring adherence to RDQA policies. You will advise on GCP and quality topics for global business partners to ensure worldwide regulatory compliance.

You will contribute to the AbbVie Quality System, drive CAPA activities, and participate in inspections. Travel up to 40% is required to cover audits across sites and affiliates.