Associate Director, Quality Assurance

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 preferred

Job 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

Key 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

 

• 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%

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

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including 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. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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https://www.abbvie.com/join-us/reasonable-accommodations.html