Global Quality Assurance Specialist

2 weeks ago


Chicago, Illinois, United States AbbVie Full time
Company Overview

A leading pharmaceutical company, AbbVie is dedicated to delivering innovative solutions for complex health issues.


About the Role

The estimated annual salary for this position is $120,000 - $180,000, depending on location and experience. This role will have a hybrid schedule, with 3 days onsite at our Lake County Headquarters.


Job Description

This leadership position supports Safety Compliance leadership in developing, implementing, maintaining, and monitoring an optimized Quality Management System for Pharmacovigilance and Patient Safety (PPS). The primary tasks involve implementing the Pharmacovigilance (PV) Investigation / CAPA and Planned Deviation process within the PPS organization. Additionally, supporting audits/inspections impacting the PV system.


Key Responsibilities
  • Independently resolves routine issues, handles complex problems, proposes potential solutions to management, and contributes to departmental policy.
  • Reviews, develops, and monitors global pharmacovigilance compliance metrics.
  • Led the preparation and conduct of PV relevant internal and external global audit and inspection processes, responses, and develops associated improvement plans.
  • Reviews and triages reports of non-conformances and potential non-conformances using professional judgment and expertise.
  • Reviews and approves exception reports, planned deviations, and CAPA tasks in line with internal and regulatory requirements.
  • Reviews, evaluates, and proposes necessary changes to regulatory guidance.
  • Evaluates and develops appropriate work tools and methodologies to enable staff to continually improve performance and productivity.


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