Auditor, RDQA Clinical Quality Audit

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

📋 Description

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

• Ensure compliance with RDQA policies and procedures.

• Assist in the development and execution of the Clinical QA quality system.

• Offer guidance and support on GCP and quality matters to business partners.

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

• Lead and engage in activities related to Clinical Audit scheduling, planning, and execution.

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

• Communicate audit findings both orally and in writing within designated timeframes.

• Review and approve Corrective Action Plans, tracking actions to completion.

• Contribute to the creation and implementation of systems and processes that meet global quality assurance requirements.

• Support the establishment or enhancement of Quality standards pertaining to Clinical audits.

• Engage in continuous improvement initiatives and projects.

• Participate in and assist with GCP inspections as needed.

• Provide support and consultation to RDQA and business partners regarding GCP regulations.

• Foster ongoing education related to quality, clinical guidelines, and regulations.

⛳️ Requirements

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

• 3–5 years of experience in the biopharmaceutical industry or with a regulatory authority.

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

• Strong analytical skills with the ability to draw conclusions from presented data.

• Capability to work effectively and efficiently in a dynamic environment with minimal supervision.

• Comprehensive awareness and understanding of clinical trial regulations, including ICH-GCP and EU Clinical Trial Directive/Regulation.

• Knowledge of industry best practices.

• Flexibility to adapt to changing tasks and the ability to prioritize effectively.

• Strong project management, interpersonal, and communication skills.

• Ability to work independently as well as collaboratively within a team.

• Willingness and ability to travel internationally.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k).

• Short-term incentive programs.

• Opportunities for international travel.