Associate Director, Quality Assurance

Overview

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. Our impact spans immunology, oncology, neuroscience, eye care, and the 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.

Locations: Irvine, CA;
Lake County, IL;
Ludwigshafen, Germany preferred

The Quality Toxins Office (QTO) provides compliance strategy, design, implementation, and continuous improvement to support global toxin quality strategy across Therapeutics and Aesthetics. The QTO assures robust global compliance programs to assure quality oversight, controls, compliance, and defining quality standards across Abb Vie s toxin enterprise.

The Associate Director, Quality Toxins Office (QTO) is responsible for helping develop, implement, and continuously enhance toxin quality strategy across Therapeutics and Aesthetics. The role will focus on fostering strong partnerships with global and site stakeholders, facilitating collaboration across the Abb Vie toxin network, and advancing quality standards for toxin-related activities. The Associate Director will leverage expertise in toxin science, regulations, and Abb Vie policies to drive risk mitigation strategies in toxin quality and compliance, shaping a culture of excellence in global toxin biosafety and biosecurity.

• 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 Abb Vie 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 Abb Vie 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 Abb Vie s SAT program, as needed

• 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…