Auditor, RDQA Clinical Quality Audit

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

📋 Description

• Implement the Clinical audit program, encompassing scheduling, planning, reporting, and resolution of Clinical audits.

• Ensure compliance with RDQA policies and procedures.

• Aid 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 the scheduling, planning, and execution of Clinical Audits.

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

• Present audit findings both verbally and in writing within designated timelines.

• Review and endorse Corrective Action Plans and monitor actions until completion.

• Assist in the creation and implementation of systems and processes that meet global quality assurance standards.

• Support the maintenance or establishment of Quality standards related to Clinical audits.

• Participate in and contribute to initiatives aimed at continuous improvement and project development.

• Engage in and assist with GCP inspections as necessary.

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

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

⛳️ Requirements

• Bachelor’s degree in a scientific field (physical, life, health), a healthcare profession (such as 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 and competency in drawing conclusions from data.

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

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

• Adaptability to changing tasks and effective prioritization.

• Proficient project management, interpersonal, and communication skills.

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

• Willingness and capability to travel internationally.

• Willingness to travel up to 40% of the time.

• Equivalent experience may be considered in lieu of the specified bachelor’s degree.

🏝️ Benefits

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

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Equal opportunity employer benefits and reasonable accommodation support for eligible applicants.