Quality Product Complaints Associate Director

The Quality Product Complaints Associate Director is responsible and accountable for providing quality oversight of the Product Complaint Quality System and the Global Recall and Defect Notification Systems. This role will support quality activities associated within the Compliance team and will partner with various internal and external cross-functional teams including Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations, and external Call Centers. The Associate Director also drives continuous improvement in Vertex quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex issues. The role requires strong leadership, people management skills and the ability to lead high performing and effective teams. Key Duties and Responsibilities include managing product complaint processes, global recall and defect notification processes, suspect product and counterfeit investigations, complaint investigations, vendor management, trend reporting, training, regulatory inspection support, and quality activities related to deviations and SOP reviews. The role requires demonstrated knowledge of GMP and GDP, product complaints, recalls, risk management, root cause analysis, inspection readiness, strong communication, project management, and leadership skills. Education and experience requirements include a Master's degree or Bachelor's degree in a scientific or allied health field with 5-8 years (Master's) or 10+ years (Bachelor's) of relevant experience.