Director, Clinical Quality Assurance
AbbVie
August 06, 2026
Remote friendly (North Chicago, IL)
United States
$182,000 - $346,000 USD yearly
Clinical Research and Development
Purpose:
Director, Clinical Quality Assurance provides global strategic quality oversight for Therapeutic Areas (TAs) within clinical development programs to ensure R&D complies with corporate policies and worldwide regulations, driving inspection readiness and proactive quality. Supports Clinical Development globally to ensure quality excellence, data integrity, first-pass approvals, adherence to the AbbVie Quality System, and execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards).
Responsibilities:
- Deliver innovative quality strategies and timely solutions to compliance issues/questions in collaboration with RDQA, R&D, GxP functions, and external service providers.
- Build and lead a high-performing TA quality team to embed quality early, prevent risks to submissions/approvals, and improve success in GCP inspections.
- Partner with Vendor QA and AREA QA to uphold GCP principles; engage across QA GxPs and deliver mitigation strategies.
- Establish collaborative relationships with clinical development leaders to ensure quality systems/objectives are understood and maintained.
- Drive development/continuous improvement and implementation of necessary GCP systems via cross-functional initiatives.
- Analyze and evaluate clinical development processes for quality and compliance; lead Program Managers and comprehensive quality assurance plans.
- Provide leadership/collaboration in health authority inspections and support resolution of findings.
- Provide expert consultation on complex quality assurance and GCP compliance inquiries.
- Promote continuous education on quality assurance and GCP guidelines.
Qualifications:
- Strong analytical and logical/thorough work organization; experienced leadership and influence.
- In-depth knowledge of quality systems, auditing standards, quality management processes; worldwide regulatory requirements and best practices for clinical development.
- Ability to operate in fast-paced, high-pressure, changing environments; project management and strong communication/negotiation.
- Bachelor’s in science (physical, life, health), a healthcare profession (e.g., nursing/pharmacy), or equivalent experience.
- Bachelor’s/Master’s or equivalent; typically 12+ years in relevant function/field; biopharmaceutical industry experience in quality/compliance or related areas, including 5 years in leadership positions.
- Ability to travel ~10–20% (including international).
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs.
Location: Lake County, IL / Irvine, CA / EU/UK.
Application instructions: Not specified in the provided text.
Director, Clinical Quality Assurance provides global strategic quality oversight for Therapeutic Areas (TAs) within clinical development programs to ensure R&D complies with corporate policies and worldwide regulations, driving inspection readiness and proactive quality. Supports Clinical Development globally to ensure quality excellence, data integrity, first-pass approvals, adherence to the AbbVie Quality System, and execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards).
Responsibilities:
- Deliver innovative quality strategies and timely solutions to compliance issues/questions in collaboration with RDQA, R&D, GxP functions, and external service providers.
- Build and lead a high-performing TA quality team to embed quality early, prevent risks to submissions/approvals, and improve success in GCP inspections.
- Partner with Vendor QA and AREA QA to uphold GCP principles; engage across QA GxPs and deliver mitigation strategies.
- Establish collaborative relationships with clinical development leaders to ensure quality systems/objectives are understood and maintained.
- Drive development/continuous improvement and implementation of necessary GCP systems via cross-functional initiatives.
- Analyze and evaluate clinical development processes for quality and compliance; lead Program Managers and comprehensive quality assurance plans.
- Provide leadership/collaboration in health authority inspections and support resolution of findings.
- Provide expert consultation on complex quality assurance and GCP compliance inquiries.
- Promote continuous education on quality assurance and GCP guidelines.
Qualifications:
- Strong analytical and logical/thorough work organization; experienced leadership and influence.
- In-depth knowledge of quality systems, auditing standards, quality management processes; worldwide regulatory requirements and best practices for clinical development.
- Ability to operate in fast-paced, high-pressure, changing environments; project management and strong communication/negotiation.
- Bachelor’s in science (physical, life, health), a healthcare profession (e.g., nursing/pharmacy), or equivalent experience.
- Bachelor’s/Master’s or equivalent; typically 12+ years in relevant function/field; biopharmaceutical industry experience in quality/compliance or related areas, including 5 years in leadership positions.
- Ability to travel ~10–20% (including international).
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs.
Location: Lake County, IL / Irvine, CA / EU/UK.
Application instructions: Not specified in the provided text.