Associate Director, Quality Risk Management

Company Description

Abb Vie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose:

The Associate Director/Director, Quality Risk Management is a strategic leader within Abb Vie’s Global Quality Systems team. This role is responsible for driving enterprise-wide excellence and standardization in R&D Quality Risk Management, providing expert oversight, and fostering a culture of proactive risk identification, mitigation, and compliance with global regulatory and industry standards. Additionally, they will lead the QRM Quality System Network, which consists of SMEs and risk practitioners across R&D.

Responsibilities:

• Serve as the strategic owner and leader of the global R&D Quality Risk Management (QRM) 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 QRM, proactively identifying, assessing, and mitigating operational and regulatory risks.
• Champion and harmonize QRM processes, documentation, and standards across R&D to achieve consistency and operational alignment.
• Lead and mentor a global network of QRM 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 QRM 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 QRM practices and policies.
• Proactively monitor and influence external regulatory trends and industry standards, advocating for the organization and elevating QRM maturity at both the company and industry level.

This role is a hybrid role with onsite at either our Lake County, IL or Irvine, CA sites.

• 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 risk management.
• Proven leadership experience in matrixed, cross‑functional environments, with demonstrated ability to influence without direct authority.
• Extensive hands‑on experience in Quality Risk Management (QRM), covering multiple domains such as Clinical Operations, Pharmacovigilance, pre‑Clinical, or Manufacturing.
• Deep knowledge of global regulatory frameworks, inspection readiness, compliance standards, and QRM methodologies, including maintenance of risk logs/registers.
• Demonstrated capability to standardize and scale quality and risk 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The…