Auditor, RDQA Clinical Quality Audit

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $84.5k - $162k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Execute the Clinical audit program, including scheduling, planning, reporting, and resolution of Clinical audits • Ensure alignment with RDQA policies and procedures • Contribute to development and implementation of the Clinical QA quality system • Provide advice and support on GCP and quality topics to business partners • Evaluate Clinical processes through audits and QA oversight activities for quality and compliance • Lead and participate in Clinical Audit scheduling, planning, and conduct activities • Conduct investigator clinical site, process, system, and Affiliate audits • Communicate audit results orally and in writing within target timeframes • Review and approve Corrective Action Plans and track actions to completion • Contribute to development and implementation of systems and processes supporting global quality assurance requirements • Support maintenance or development of Quality standards relating to Clinical audit • Contribute to continuous improvement initiatives and projects • Participate in and support GCP inspections as required • Provide support and consultation to RDQA and business partners regarding GCP regulations • Promote continuous education on quality, clinical guidelines, and regulations

🎯 Requirements

• Bachelor’s degree in science (physical, life, health), a health care 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 and ability to draw conclusions from presented data • Ability to work effectively and efficiently in a dynamic environment with minimal supervision • High-level 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 assignments and ability to prioritize effectively • Good project management, interpersonal, and communication skills • Ability to work independently and as part of a team • Willingness and ability to perform international travel

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • International travel opportunities