Global Clinical QA Lead — Quality Strategy & Compliance

Regulatory Jobs; North Chicago (IL); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

PTO and holidays

Medical/dental/vision insurance

401(k) + long-term incentives

Job summary

AbbVie is seeking an experienced RDQA professional to lead quality assurance activities across global trials, ensuring regulatory readiness and data integrity. This hybrid role supports multiple US locations and collaborates with cross-functional teams to uphold the AbbVie Quality System.

You will oversee audits, CAPAs, and inspection readiness, while mentoring AREA staff and aligning strategies with regulatory expectations to accelerate program timelines.

Qualifications

• Bachelor's degree in Biology, Nursing, Pharmacy or other medical science, with equivalent technical experience.
• 8+ years of biopharmaceutical or medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or related development functions, including 3 years in leadership positions.

Responsibilities

• Support assigned countries and region; implement proactive quality management activities.
• Maintain close collaboration with RDQA functions impacting clinical research within Affiliates.
• Build relationships with clinical development leaders to advance AbbVie Quality System and drive quality excellence.
• Oversee quality and compliance in a regulated environment; align with AbbVie policies and country/regional standards.
• Lead risk identification and mitigation strategies for clinical research activities, including trials.
• Establish quality measures and drive quality strategy in designated countries/region.
• Manage governance in relation to the One AbbVie Quality System; identify trends and drive regulatory preparedness.
• Ensure understanding of quality requirements for clinical research within Affiliates.
• Develop standards to measure quality and stay aware of applicable regulations.
• Support supplier visits, audits and vendor qualifications.
• Develop inspection strategy and provide inspection-readiness support; participate in inspections as needed.
• Mentor AREA Managers/Associates or take on line management.

Skills

Analytical skills

Communication

Presentation skills

Negotiation

Influencing

Education

Bachelor's degree

Job description

AbbVie is seeking an experienced RDQA professional to lead quality assurance activities across global trials, ensuring regulatory readiness and data integrity. This hybrid role supports multiple US locations and collaborates with cross-functional teams to uphold the AbbVie Quality System.

You will oversee audits, CAPAs, and inspection readiness, while mentoring AREA staff and aligning strategies with regulatory expectations to accelerate program timelines.