Director, Global Quality Complaint Operations

About the role

The Director, Global Quality Complaint Operations leads end‑to‑end complaint execution for AbbVie’s post‑market portfolio, including cosmetics, pharmaceuticals, biologics, combination products and medical devices. This senior role defines the global strategy for post‑marketing quality operations and ensures compliance with worldwide regulatory requirements.

Key responsibilities

• Provide global strategic direction and vision for a worldwide team handling complaint intake, processing, reportability, and medical device reporting.
• Oversee global and U.S. complaint handling processes to ensure proper evaluation, regulatory reporting, and documentation for all product types.
• Maintain the effectiveness of the Operational Quality System, including quality policies, procedures, KPIs, and CAPA investigations.
• Manage capacity and demand planning for resource allocation, new product introductions, market expansions, acquisitions, and real‑time actions.
• Partner with internal functions such as Device Safety, Manufacturing, Quality, Regulatory, Commercial, Pharmacovigilance, and Global Medical Information to leverage quality outputs and improve patient and customer experience.

Required profile

• Extensive experience in global quality and complaint management within the pharmaceutical, biotech, or medical device industry.
• Proven leadership of cross‑functional, geographically dispersed teams.
• Strong understanding of global regulatory requirements for medical devices, combination products, pharmaceuticals, and biologics.
• Ability to analyze complex information and make decisions on reportability under regulatory guidelines.

Required skills

• Knowledge of medical device reporting and post‑marketing surveillance processes.
• Experience with quality system implementation, maintenance, and continuous improvement.
• Familiarity with CAPA (Corrective and Preventive Action) investigations.