Auditor, RDQA Clinical Quality Audit - Remote

Summary

AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. The Auditor will execute the Clinical audit program, including scheduling, planning, reporting, and resolution, while supporting the development of the Clinical QA quality system and advising business partners on GCP and quality compliance.

Responsibilities

• Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities
• Lead and participate in Clinical Audit scheduling, planning and conduct activities to assess compliance with regulations, guidelines, AbbVie policies and procedures and sponsor requirements. Clinical audit types include investigator clinical site, process, system and Affiliate audits
• Effectively communicate audit results, both orally and in writing, within target timeframes
• Review and approve Corrective Action Plans submitted in response to audit observations within target timeframes and tracking of actions to completion
• Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements. Supports maintenance or development of Quality standards relating to Clinical audit
• Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies
• Participate in and support GCP inspections, as required
• Provide support and consultation to RDQA and business partners with regards to GCP regulations
• Promote continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff

Skills

• 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

Qualifications

Must Haves

• 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

Benefits

• Paid time off, including vacation, holidays, and sick leave, for eligible employees
• Medical, dental, and vision insurance for eligible employees
• 401(k) for eligible employees
• Eligibility to participate in short-term incentive programs
• Remote work arrangement