Director, Clinical Quality Assurance — Global QA Strategy

Regulatory Jobs; Chicago (IL); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

AbbVie seeks a Director, Clinical Quality Assurance to lead global quality oversight for Therapeutic Areas within clinical development programs. You will ensure compliance with policies and worldwide regulations, shaping inspection readiness and QA views across R&D.

Reporting to Senior Director, Clinical Quality Assurance, you will build strong teams, drive GCP systems, CAPA and risk management, and partner with development leaders to embed quality into development milestones while enabling

Qualifications

• Strong analytical skills and the ability to organize work logically and succinctly.
• Ability to work at an experienced level, leading interactions with partners at all levels.
• Excellent communication and negotiation skills; able to influence and manage difficult conversations.
• Extensive knowledge of global regulatory requirements and industry best practices for clinical development.

Responsibilities

• Delivers innovative quality strategies and solutions across RDQA and R&D teams to address compliance issues.
• Builds a strategic, high-performing QA team within Therapeutic Areas to embed quality early in Development Programs.
• Leads cross-functional collaborations to ensure GCP systems, CAPA, Change Management, and Quality Risk Management are in place.
• Maintains alignment with development leaders to support AbbVie quality objectives and inspection readiness.
• Provides guidance during health authority inspections and supports resolution of findings.

Skills

Leadership

GCP Knowledge

Quality Systems

Regulatory Compliance

Education

Bachelor's degree in science

Master's degree or equivalent

Job description

AbbVie seeks a Director, Clinical Quality Assurance to lead global quality oversight for Therapeutic Areas within clinical development programs. You will ensure compliance with policies and worldwide regulations, shaping inspection readiness and QA views across R&D.

Reporting to Senior Director, Clinical Quality Assurance, you will build strong teams, drive GCP systems, CAPA and risk management, and partner with development leaders to embed quality into development milestones while enabling