Associate Director, Global Quality and Compliance Excellence
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About The Position
The Associate Director, Global Quality and Compliance Excellence at AbbVie plays a pivotal role in ensuring that the company's operations meet the highest standards of quality and compliance. This position requires advanced subject matter expertise in global quality standards, current Good Manufacturing Practices (cGMP), and external agency regulations. The Associate Director will lead the preparedness for regulatory inspections and audits across AbbVie’s global network, ensuring that all sites are compliant with the necessary standards. This involves a close collaboration with AbbVie Manufacturing Site leadership, Quality Lab leadership, global functional groups, and Third Party Manufacturers. The role is crucial in fostering a quality culture within the organization by conducting mock audits, coaching site leadership on identified opportunities, and maintaining clear roles and responsibilities across teams. In this role, the Associate Director will be responsible for providing guidance on quality concerns and preparing all global sites for future inspections and audits in various areas, including small molecule pharmaceuticals, biologics, combination products, medical devices, tissue, and cosmetics. The position requires the development of updated audit plans, inspection readiness plans, and corrective actions to ensure compliance with global standards. The Associate Director will also provide strategic input to site and global leadership teams, helping them prioritize initiatives that advance the quality culture and maintain an inspection-ready state. The Associate Director will ensure that all quality elements are delivered to facilitate new product launches and will provide technical and regulatory guidance on compliance-related events across the network. This role is integral to AbbVie’s overall compliance strategy, requiring collaboration with Quality Centers of Excellence to review regulatory intelligence and assess vulnerabilities against inspection findings. The Associate Director will serve as a key stakeholder for cross-functional teams, ensuring that business objectives are met while maintaining compliance with local, divisional, and corporate policies as well as global regulations.
