Role OverviewThe Auditor, RDQA Clinical Quality Audit is responsible for the execution of the Clinical audit program, ensuring alignment with RDQA policies and procedures, and contributing to the development and implementation of the Clinical QA quality system.
What You Will Do
The Auditor will lead and participate in Clinical Audit scheduling, planning, and conduct activities, review and approve Corrective Action Plans, and advance the AbbVie Quality System through contribution to the development and implementation of systems and processes.
Why It Might Be a Fit
The ideal candidate will have a strong analytical skillset, ability to work effectively in a dynamic environment, and high level of awareness and understanding of clinical trial regulations and industry best practices.
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 the ability to draw conclusions from presented data
- Ability to work effectively and efficiently in a dynamic environment with minimal supervision
- High level of awareness and understanding of clinical trial regulations (e.g. ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices
- Flexibility to adapt to changing assignments and ability to effectively prioritize
- Good project management, interpersonal, and communication skills with 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/vision insurance
- 401(k)
- Short-term incentive programs
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