The Associate Director, Quality Change Management is the strategic leader for R&D Quality Change Management within AbbVie’s Global Quality Systems team. This role drives enterprise-wide standardization and excellence by providing expert oversight and promoting proactive identification, communication, implementation, and governance of change in alignment with global regulatory requirements and industry standards. The Associate Director also leads the QCM Quality System Network, comprising subject matter experts and change practitioners across R&D.
Responsibilities:
The Associate Director, Quality Change Management is responsible to:
- 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 subject matter experts (SMEs) and practitioners, fostering an enterprise-wide culture of knowledge-sharing, collaboration, 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.