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AbbVie

Global biopharmaceutical company developing medicines

Associate Director - Change Management

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNorth Chicago, IL, USAIn-person

About the Job

Requirements

  • A bachelor's or advanced degree in a scientific discipline, life sciences, engineering, or a related field.
  • At least 8 years of experience in the pharmaceutical or biotechnology industry, including relevant quality change management focus, or at least 5 years with an MS or PhD.
  • Proven leadership experience in matrixed, cross-functional environments and the ability to influence without direct authority.
  • Extensive hands-on experience in Quality Change Management covering multiple domains such as Clinical Operations, Pharmacovigilance, pre-Clinical, or Manufacturing.
  • Deep knowledge of global regulatory frameworks, inspection readiness, compliance standards, and Quality Change Management methodologies.
  • Demonstrated ability to standardize and scale quality and change management processes globally to enhance operational efficiency and reduce complexity.
  • A track record of leading organizations through ambiguity and transformation while balancing competing priorities.
  • Experience engaging with senior leadership and developing subject matter experts.

Responsibilities

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

About the Company

AbbVie

Global biopharmaceutical company developing medicines

AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.

Company size
10,001+
Company stage
IPO
Headquarters
North Chicago, IL
Founded
1888

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