Auditor, RDQA Clinical Quality Audit

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

📋 Description

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

• Ensure compliance with RDQA policies and procedures.

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

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

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

• Lead and participate in the scheduling, planning, and execution of investigator clinical site, process, system, and Affiliate audits.

• Communicate audit findings both verbally and in writing within specified timeframes.

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

• Enhance the AbbVie Quality System by developing and implementing systems and processes.

• 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 support and consultation to RDQA and business partners.

• Encourage 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 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 insights from presented data.

• Capability to work effectively and efficiently in a fast-paced environment with minimal supervision.

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

• Flexibility to adapt to changing responsibilities 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 capacity for international travel.

• Travel may be required up to 40% of the time.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Option for remote work.

• Commitment to equal opportunity employment.

• Reasonable accommodations for applicants with disabilities.