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 resolution of Clinical audits.

• Ensure compliance with RDQA policies and procedures.

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

• Offer advice and support regarding GCP and quality issues to business partners.

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

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

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

• Convey audit findings both verbally and in writing within designated timeframes.

• Review and approve Corrective Action Plans, ensuring actions are tracked to completion.

• Assist in the development and implementation of systems and processes that fulfill global quality assurance requirements.

• Aid in the maintenance or development of Quality standards related to Clinical audits.

• Contribute to initiatives and projects aimed at continuous improvement.

• Participate in and support GCP inspections as necessary.

• Provide GCP regulatory guidance and consultation to RDQA and business partners.

• Advocate for ongoing education on quality, clinical guidelines, and regulations.

⛳️ Requirements

• Bachelor’s degree in a scientific field (physical, life, or 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 authority.

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

• Strong analytical abilities with a talent for drawing conclusions from data.

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

• High-level awareness and comprehension of clinical trial regulations, including ICH-GCP and EU Clinical Trial Directive/Regulation.

• Familiarity with industry best practices.

• Adaptability to changing assignments and proficiency in prioritizing tasks effectively.

• Strong project management, interpersonal, and communication skills.

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

• Willingness and capability to undertake international travel.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Opportunities for international travel.