Associate Director, QA
AbbVie
August 18, 2026
Remote friendly (North Chicago, IL)
United States
$141,500 - $268,500 USD yearly
Operations
Purpose:
As the Head of the Americas Clinical Quality Audit team, leads a high performing team to deliver on the Clinical Audit strategy and assure the quality and compliance of AbbVie clinical trials and studies in the region.
Responsibilities:
- Assure quality and compliance in a regulated environment (AbbVie policies/procedures, country requirements, applicable standards and regulations).
- Contribute to Clinical Audit Team strategy and ensure alignment with RDQA policies/procedures.
- Advance the AbbVie Quality System through collaboration with business partners and other GxP RDQA functions; implement systems/processes for global quality assurance.
- Lead and develop teams by creating an inclusive environment, focusing on people development, setting expectations, coaching for performance.
- Lead/develop Clinical Auditors (Americas) for all clinical audit types; drive cross-functional quality.
- Provide leadership for the risk-based clinical audit program; execute complex audits; resolve non-compliances with auditees.
- Deliver quality strategies/solutions with GxP RDQA functions to address compliance issues.
- Drive improvement of quality and clinical systems to assure compliance with regulations and corporate policies.
- Analyze/evaluate clinical development processes for quality/compliance.
- Provide expert advice on clinical regulations and expectations to RDQA and business colleagues.
- Provide strategic input to inspection support model; support GCP inspections onsite or remotely.
- Promote continuous education on quality and clinical guidelines.
Qualifications:
- Bachelor’s degree in science/healthcare (e.g., nursing, pharmacy) or equivalent experience.
- 7+ years in pharma (clinical development, clinical trials regulatory affairs, and/or quality assurance) or with a regulatory authority.
- Detailed knowledge of quality systems and auditing standards.
- Extensive knowledge of worldwide clinical regulatory requirements and standards (e.g., ICH, ISO).
- Excellent communication, negotiation, and influencing skills; strong analytical and risk-management skills.
- Experience leading cross-functional, multi-location teams; strong strategic leadership.
- Domestic and international travel willingness.
Benefits/Instructions:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for long-term incentive programs.
As the Head of the Americas Clinical Quality Audit team, leads a high performing team to deliver on the Clinical Audit strategy and assure the quality and compliance of AbbVie clinical trials and studies in the region.
Responsibilities:
- Assure quality and compliance in a regulated environment (AbbVie policies/procedures, country requirements, applicable standards and regulations).
- Contribute to Clinical Audit Team strategy and ensure alignment with RDQA policies/procedures.
- Advance the AbbVie Quality System through collaboration with business partners and other GxP RDQA functions; implement systems/processes for global quality assurance.
- Lead and develop teams by creating an inclusive environment, focusing on people development, setting expectations, coaching for performance.
- Lead/develop Clinical Auditors (Americas) for all clinical audit types; drive cross-functional quality.
- Provide leadership for the risk-based clinical audit program; execute complex audits; resolve non-compliances with auditees.
- Deliver quality strategies/solutions with GxP RDQA functions to address compliance issues.
- Drive improvement of quality and clinical systems to assure compliance with regulations and corporate policies.
- Analyze/evaluate clinical development processes for quality/compliance.
- Provide expert advice on clinical regulations and expectations to RDQA and business colleagues.
- Provide strategic input to inspection support model; support GCP inspections onsite or remotely.
- Promote continuous education on quality and clinical guidelines.
Qualifications:
- Bachelor’s degree in science/healthcare (e.g., nursing, pharmacy) or equivalent experience.
- 7+ years in pharma (clinical development, clinical trials regulatory affairs, and/or quality assurance) or with a regulatory authority.
- Detailed knowledge of quality systems and auditing standards.
- Extensive knowledge of worldwide clinical regulatory requirements and standards (e.g., ICH, ISO).
- Excellent communication, negotiation, and influencing skills; strong analytical and risk-management skills.
- Experience leading cross-functional, multi-location teams; strong strategic leadership.
- Domestic and international travel willingness.
Benefits/Instructions:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for long-term incentive programs.