AbbVie · 1 day ago
Associate Director, Quality Risk Management
Irvine, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$138K/yr - $261K/yr
8+ years expAbbVie is committed to delivering innovative medicines and solutions that tackle serious health issues. The Associate Director, Quality Risk Management will lead the global R&D Quality Risk Management system, ensuring compliance and driving excellence across functions.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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
Qualification
Required
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
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-07
2026-01-06
2026-01-06
Company data provided by crunchbase