Purpose:

The Director, Global Quality Complaint Operations leads the end to end complaint execution (includes complaint intake, processing, reportability, and medical device reporting) and is responsible for leading the global strategy for Post Marketing Quality Operations.

This role is responsible for all AbbVie post market products (cosmetic, pharmaceutical, biologic, combination, devices) and investigation coordination of pre-market device regulatory responsibility. This role has oversight of the health of the Operational Quality System including meeting global regulatory requirements, medical device reporting, KPIs, best in class timeliness and quality. This role also has direct operational responsibility for capacity and demand planning for resource management including new product introductions, market expansions and acquisitions and real time actions, as well as training program including new team member hiring, process updates, new products and cross training

This organization will partner with direct complaint execution functions (including Device Safety, Manufacturing sites, labs, Product Security), indirect complaint execution support (including Quality, Third Party Manufacturing, Product Support, Device Safety, Regulatory) and Global Commercial based on therapeutic areas including Patient Support Programs,  Marketing, Pharmacovigilance, Global Medical Information and others to leverage PQC outputs to enhance the patient and customer experience.

Responsibilities:

• Provide global strategic direction and vision for team located around the world which is responsible for the end-to-end complaint management process.
• Oversee global and US complaint handling process to ensure complaints related to medical devices, combination products, pharmaceutical and biologics products are appropriately handled, evaluated, and reported to regulatory agencies worldwide.
• Responsible for implementing and maintaining the effectiveness of the quality system through implementation and maintenance of Quality policies, procedures and systems to support and maintain appropriately documented complaint investigations and associated CAPA investigations.
• Ensure complaint investigation and processing of complaint including associated documents follow global complaint handling regulations and internal procedures. Ability to analyze information obtained and make decisions for reportability under regulations.
• Establish annual budgets, forecasts and resources. Make necessary changes and plans to ensure that annual budgets and long-range plans are met.
• Handle escalated conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service.
• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations. Perform periodic audits of complaint handling records to ensure compliance with requirements.
• Represent the complaint handling functions during internal/external audits and inspections. Serves as company representative to various US and international regulatory bodies (regulatory authorities and notified bodies). Interacts directly with designated point of contact.
• Monitor workflow to ensure quantity and quality are consistently met. Continually initiate plans to maximize use of resources, and/or take corrective action to resolve. Involved in interviewing, hiring, training employees, rewarding accomplishments, and the performance management process.
• Drive continuous improvement and development and evaluation of metrics and quality indicators to oversee efforts to address underperformance or otherwise to drive continuous improvement in performance.