Director, Clinical Quality Assurance
AbbVie
5 days ago
Remote friendly (North Chicago, IL)
United States
$182,000 - $346,000 USD yearly
Clinical Research and Development
Purpose:
The Director, Clinical Quality Assurance is responsible for developing and implementing global strategic quality oversight for Therapeutic Areas within clinical development programs to ensure R&D compliance with corporate policies and worldwide regulations. Provides strategic leadership for inspection readiness and QA perspectives, embedding quality requirements into improvement initiatives. 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.
Responsibilities:
- Deliver innovative quality strategies through collaboration across RDQA, R&D, other GxP functions, and external service providers.
- Build a high-performing TA team to embed quality early, prevent risks to submissions/approvals, and improve GCP inspection outcomes.
- Partner with Vendor QA and AREA QA; engage across QA GxPs and develop mitigation strategies for critical partners.
- Lead continuous improvement and implementation of GCP systems via cross-functional initiatives.
- Analyze and evaluate clinical development processes for quality and compliance; lead program managers and comprehensive quality assurance plans.
- Lead strategic planning and ensure resources for essential QA activities.
- Provide leadership during health authority inspections and support resolution of findings.
- Provide expert consultation on complex QA/GCP compliance inquiries.
- Promote continuous education on QA and GCP guidelines.
Qualifications:
- Strong analytical and logical organization skills.
- Experienced leadership with business partners; owns toughest challenges and influences without authority.
- Thorough knowledge of quality systems, auditing, quality management; strong regulatory and industry best-practice knowledge.
- Ability to work autonomously in fast-paced, high-pressure environments; flexible and able to prioritize.
- Project management, interpersonal, and communication skills; excellent negotiation/influencing.
- Leadership competencies: motivation, cultural awareness, engagement, relationship building, sound judgment; manage sensitive proprietary information.
- Extensive biopharmaceutical clinical development knowledge.
- Bachelor’s degree in science/healthcare profession or equivalent; typically 12+ years in relevant function.
- Biopharma QA/compliance and/or related development experience including 5 years in leadership roles.
- Travel 10–20%.
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.
Reports to:
Senior Director, Clinical Quality Assurance.
The Director, Clinical Quality Assurance is responsible for developing and implementing global strategic quality oversight for Therapeutic Areas within clinical development programs to ensure R&D compliance with corporate policies and worldwide regulations. Provides strategic leadership for inspection readiness and QA perspectives, embedding quality requirements into improvement initiatives. 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.
Responsibilities:
- Deliver innovative quality strategies through collaboration across RDQA, R&D, other GxP functions, and external service providers.
- Build a high-performing TA team to embed quality early, prevent risks to submissions/approvals, and improve GCP inspection outcomes.
- Partner with Vendor QA and AREA QA; engage across QA GxPs and develop mitigation strategies for critical partners.
- Lead continuous improvement and implementation of GCP systems via cross-functional initiatives.
- Analyze and evaluate clinical development processes for quality and compliance; lead program managers and comprehensive quality assurance plans.
- Lead strategic planning and ensure resources for essential QA activities.
- Provide leadership during health authority inspections and support resolution of findings.
- Provide expert consultation on complex QA/GCP compliance inquiries.
- Promote continuous education on QA and GCP guidelines.
Qualifications:
- Strong analytical and logical organization skills.
- Experienced leadership with business partners; owns toughest challenges and influences without authority.
- Thorough knowledge of quality systems, auditing, quality management; strong regulatory and industry best-practice knowledge.
- Ability to work autonomously in fast-paced, high-pressure environments; flexible and able to prioritize.
- Project management, interpersonal, and communication skills; excellent negotiation/influencing.
- Leadership competencies: motivation, cultural awareness, engagement, relationship building, sound judgment; manage sensitive proprietary information.
- Extensive biopharmaceutical clinical development knowledge.
- Bachelor’s degree in science/healthcare profession or equivalent; typically 12+ years in relevant function.
- Biopharma QA/compliance and/or related development experience including 5 years in leadership roles.
- Travel 10–20%.
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.
Reports to:
Senior Director, Clinical Quality Assurance.