Global Director, Clinical Quality Assurance

BioSpace; North Chicago (IL); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Director of Clinical Quality Assurance to provide global quality oversight across therapeutic areas in clinical development. The role ensures compliance with AbbVie policies and worldwide regulations, and leads strategic quality initiatives to embed quality early.

You will drive inspection readiness, CAPA, and continuous improvement in GCP systems, partnering with clinical development leaders and cross-functional teams to achieve R&D goals.

Qualifications

• Extensive knowledge of clinical development and biopharmaceutical quality systems.
• Experience with GCP, ICH guidelines, and global regulatory expectations.
• Proven ability to lead large, cross-functional teams across regions.
• Strong strategic thinking and problem-solving in a fast-paced environment.
• Demonstrated success in inspection readiness and CAPA management.
• Ability to travel 10–20% internationally as required.

Responsibilities

• Develop and implement global quality oversight for Therapeutic Areas in clinical development.
• Ensure compliance with AbbVie policies and worldwide regulations across RDQA.
• Lead strategic quality initiatives to embed quality in development programs.
• Prepare for and manage regulatory inspections and interactions with health authorities.
• Coach Program Managers and build high-performing teams across functions.
• Drive continuous improvement of GCP systems and documentation standards.

Skills

Quality leadership

GCP knowledge

Regulatory compliance

Cross-functional leadership

Audit readiness

Strategic planning

Education

Bachelor's or Master in science or healthcare

Advanced degree or relevant certification

Job description

AbbVie is seeking a Director of Clinical Quality Assurance to provide global quality oversight across therapeutic areas in clinical development. The role ensures compliance with AbbVie policies and worldwide regulations, and leads strategic quality initiatives to embed quality early.

You will drive inspection readiness, CAPA, and continuous improvement in GCP systems, partnering with clinical development leaders and cross-functional teams to achieve R&D goals.