AbbVie · 16 hours ago
Associate Director, Quality Assurance
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expAbbVie is dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. The Associate Director, Quality Toxins Office is responsible for developing and implementing toxin quality strategies, fostering partnerships, and ensuring compliance with quality standards across the organization.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Develop effective relationships with toxin stakeholders to support strategic projects, operational improvements, and implementation of best practices in toxin quality, standards and compliance
Champion the definition, advancement, and communication of quality standards for toxins, ensuring alignment with organizational objectives and evolving regulatory requirements, and integrating global quality systems throughout the toxin network
Support QTO risk mitigation strategies for inventory controls, biosafety, biosecurity, and regulatory compliance, working proactively to address emerging risks
Independently drive identification of potential quality risks for inventory controls, biosafety, biosecurity, and regulatory compliance; facilitate and drive vision for continued process improvement
Partner with toxin stakeholders to implement a 'Quality Beyond Compliance' approach in toxin management, recommending and designing forward-looking quality policies and procedures to ensure AbbVie remains best-in-class in the toxin space
Lead the design and implementation of toxin quality governance, including the development of process and procedure documents to support AbbVie’s global toxin network and enterprise toxin policy requirements
Utilize critical thinking and effective negotiation skills to ensure quality compliance across the toxin enterprise, connecting complex concepts and designing/implementing tailored solutions to address quality risks and opportunities
Coordinate and support preparations for inspections, regulatory reviews, advocating for quality requirements and standards
Support Centers for Disease Control (CDC) inspections of AbbVie’s SAT program, as needed
Qualification
Required
Bachelor's degree or equivalent in a related science field
8+ years pharmaceutical industry experience, with preferably 3+ years working with Select Agents and Toxins (SAT) and proven understanding of toxin processes/systems, preferably in quality compliance roles
Sound knowledge of toxin research regulations and compliance requirements with ability to strategically interpret and communicate requirements
Demonstrated ability to build collaborative relationships, communicate across cultures, and shape organizational quality standards
Demonstrated application of critical thinking and the ability to independently develop and implement strategic quality solutions in support of compliance principles for toxin research
Successful and progressive leadership experience in managing projects and/or teams and in cross functional execution
Experienced in having a direct role in supporting external regulatory inspections
Excellent written and oral communication skills, project management, influencing and persuasion skills, matrix managing without direct authority, and collaboration/negotiation for mutually beneficial outcomes
Willingness to travel up to 20%
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
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
2026-01-23
2026-01-20
2026-01-20
Company data provided by crunchbase