Global Quality Change Management Lead

ABBVIE; North Chicago (IL); On-site; USD 142,000 - 269,000; Full time

Job summary

AbbVie seeks an Associate Director, Quality Change Management to lead the R&D QCM system, driving standards, governance, and proactive change oversight across functions. You will mentor SMEs, advise internal stakeholders, and ensure regulatory alignment in a global enterprise.

The role emphasizes evolving quality systems, SOPs, training materials, and inspection readiness while championing standards across R&D teams worldwide.

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), with relevant focus in quality change management.
• Proven leadership experience in matrixed, cross-functional environments, with demonstrated ability to influence without direct authority.
• Extensive hands-on experience in Quality Change Management (QCM), covering multiple domains such as Clinical Operations, Pharmacovigilance, pre-Clinical, or Manufacturing.
• Deep knowledge of global regulatory frameworks, inspection readiness, compliance standards, and QCM methodologies
• Demonstrated capability to standardize and scale quality and change management processes globally to enhance operational efficiency and reduce complexity.
• Strong change agility, with a track record of effectively leading organizations through ambiguity and transformation while balancing competing priorities.
• Exceptional communication, interpersonal, and mentoring skills, including experience engaging with senior leadership and developing SMEs.

Responsibilities

• Serve as the strategic owner and leader of the global R&D Quality Change Management (QCM) system, driving sustainable excellence and compliance across functions.
• Design, develop, and continuously improve quality systems, standards, practices, and supporting tools, ensuring alignment with evolving regulatory and industry expectations.
• Establish and maintain robust governance structures for QCM, ensuring changes are consistently identified, assessed, approved, implemented, communicated, and monitored in accordance with applicable regulatory requirements.
• Champion and harmonize QCM processes, documentation, and standards across R&D to achieve consistency and operational alignment.
• Lead and mentor a global network of QCM SMEs and practitioners, fostering an enterprise-wide culture of knowledge-sharing and best practice adoption.
• Act as the primary consultant and advisor to internal R&D stakeholders, providing QCM guidance, regulatory updates, issue resolution, and process implementation support.
• Oversee the creation, maintenance, and harmonization of process documentation, SOPs, and training materials to ensure effective knowledge transfer and compliance.
• Define, monitor, and report on key quality and risk metrics, using data-driven insights to inform leadership, drive continuous improvement, and ensure accountability.
• Ensure organization-wide inspection readiness; represent the company during Health Authority inspections, including responding to and defending QCM practices and policies.
• Proactively monitor and influence external regulatory trends and industry standards, advocating for the organization and elevating QCM maturity at both the company and industry level.

Skills

Leadership

Influence without authority

Regulatory awareness

Communication

Mentoring

Change management

Data-driven

Education

Bachelor’s or advanced degree in science/engineering

Job description

AbbVie seeks an Associate Director, Quality Change Management to lead the R&D QCM system, driving standards, governance, and proactive change oversight across functions. You will mentor SMEs, advise internal stakeholders, and ensure regulatory alignment in a global enterprise.

The role emphasizes evolving quality systems, SOPs, training materials, and inspection readiness while championing standards across R&D teams worldwide.