Auditor, RDQA Clinical Quality Audit

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Implement the Clinical audit program, which includes scheduling, planning, reporting, and resolving Clinical audits.

• Ensure compliance with RDQA policies and procedures, contributing to the development and execution of the Clinical QA quality system.

• Offer guidance and support on GCP and quality-related subjects to business partners.

• Assess Clinical processes through audits and QA oversight activities to ensure quality and compliance.

• Lead and engage in the scheduling, planning, and execution of Clinical Audits.

• Perform audits of investigator clinical sites, processes, systems, and Affiliates.

• Deliver audit results both verbally and in writing within established timeframes.

• Review, approve, and monitor the completion of Corrective Action Plans.

• Enhance the AbbVie Quality System by developing and implementing systems and processes that meet global quality assurance standards.

• Aid in the maintenance or development of Quality standards associated with Clinical audits.

• Contribute to initiatives and projects aimed at continuous improvement.

• Participate in and provide support for GCP inspections as needed.

• Offer GCP regulatory assistance and consultation to RDQA and business partners.

• Advocate for ongoing education regarding quality and clinical guidelines and regulations.

⛳️ Requirements

• Bachelor's degree in a scientific field (physical, life, health), a healthcare profession (e.g., nursing or pharmacy), or equivalent experience.

• 3–5 years of experience in the biopharmaceutical sector or with a regulatory body.

• 3–5 years of experience in Quality Assurance and/or Clinical Research Development.

• Strong analytical abilities with the capacity to draw insights from presented data.

• Proven ability to function effectively and efficiently in a fast-paced environment with minimal supervision.

• Comprehensive understanding of clinical trial regulations, including ICH-GCP and EU Clinical Trial Directive/Regulation, as well as industry best practices.

• Ability to adapt to changing tasks and effectively prioritize responsibilities.

• Strong project management, interpersonal, and communication skills.

• Capability to work independently as well as collaboratively in a team setting.

• Willingness and capacity to undertake international travel.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Opportunities for international travel.