Global Quality Change Management Lead (Associate Director)

AbbVie Inc.; North Chicago (IL); On-site; USD 170,000 - 230,000; Full time

Job summary

AbbVie Inc. in North Chicago, IL seeks an Associate Director of Quality Change Management to lead the global R&D QCM program within our Global Quality Systems.

This role drives standardization, governance, and proactive change management across functions in alignment with regulatory expectations. You will design and improve quality systems, lead a network of QCM SMEs, and act as a key consultant to internal stakeholders.

Qualifications

• Bachelor’s or advanced degree in a scientific discipline, life sciences, engineering, or a related field.
• Minimum of 8 years’ experience in the pharmaceutical or biotechnology industry (or 5+ years with an MS/PhD).
• Proven leadership in matrixed environments with ability to influence without direct authority.
• Extensive hands-on experience in Quality Change Management across multiple domains (Clinical Operations, Pharmacovigilance, pre-Clinical, Manufacturing).
• Deep knowledge of global regulatory frameworks, inspection readiness, and QCM methodologies.

Responsibilities

• Serve as the strategic owner and leader of the global R&D Quality Change Management system.
• Design, develop, and improve quality systems, standards, practices, and supporting tools.
• Establish governance structures for QCM ensuring changes are identified, assessed, approved, implemented, communicated, and monitored.
• Harmonize QCM processes and standards across R&D for consistency.
• Lead a global network of QCM SMEs and practitioners and promote knowledge sharing.
• Advise internal R&D stakeholders with QCM guidance, regulatory updates, issue resolution, and process implementation support.
• Oversee creation and maintenance of process documentation, SOPs, and training materials.
• Define, monitor, and report key quality and risk metrics for leadership and improvement.
• Ensure organization-wide inspection readiness and respond during Health Authority inspections.
• Monitor external regulatory trends and advocate for QCM maturity within the company.

Skills

Leadership

Quality management

Regulatory knowledge

Cross-functional influence

Stakeholder engagement

Mentoring SMEs

Education

Bachelor’s or advanced degree in life sciences, engineering, or related field

Job description

AbbVie Inc. in North Chicago, IL seeks an Associate Director of Quality Change Management to lead the global R&D QCM program within our Global Quality Systems.

This role drives standardization, governance, and proactive change management across functions in alignment with regulatory expectations. You will design and improve quality systems, lead a network of QCM SMEs, and act as a key consultant to internal stakeholders.