Clinical QA Auditor — GCP Compliance & Audit Lead

Internationalinsuranceprofessionals; Chicago (IL); Remote; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Clinical QA professional to oversee the clinical audit program, including scheduling, planning and reporting. You will ensure compliance with global regulations and contribute to the quality system across RDQA. You will advise partners on GCP topics to ensure worldwide compliance.

The role requires a Bachelor's in science or healthcare, 3–5 years in biopharma or regulatory, and strong analytical and communication skills with ability to travel internationally.

Qualifications

• Bachelor's degree in science (physical, life, health) or a health care profession (e.g., nursing or pharmacy) or equivalent experience.
• Strong analytical skills and the ability to draw conclusions from presented data.
• 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.
• Knowledge of clinical trial regulations (ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices.

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.
• 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.
• 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

Analytical skills

Project management

Interpersonal skills

Communication skills

Education

Bachelor's degree in science/healthcare

Job description

AbbVie is seeking a Clinical QA professional to oversee the clinical audit program, including scheduling, planning and reporting. You will ensure compliance with global regulations and contribute to the quality system across RDQA. You will advise partners on GCP topics to ensure worldwide compliance.

The role requires a Bachelor's in science or healthcare, 3–5 years in biopharma or regulatory, and strong analytical and communication skills with ability to travel internationally.