Associate Director, Quality Assurance

AbbVie • Irvine, CA

7d

About The Position

Company Description:
AbbVie'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.Locations: Irvine, CA; Lake County, IL; Ludwigshafen, Germany preferredJob Purpose:
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 AbbVie'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 AbbVie toxin network, and advancing quality standards for toxin-related activities. The Associate Director will leverage expertise in toxin science, regulations, and AbbVie policies to drive risk mitigation strategies in toxin quality and compliance, shaping a culture of excellence in global toxin biosafety and biosecurity

Requirements

• Bachelor's degree or equivalent in a related science field.
• 8+ years pharmaceutical industry experience, with at least 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%

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

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees