Teresa Gorecki

Teresa Gorecki is a senior Quality and Compliance executive with over 25 years of experience across pharmaceutical, biopharmaceutical, medical device, and consumer healthcare industries. She specializes in integrating quality strategy with business operations to enable robust supply chains, successful product commercialization, and sustained regulatory compliance. Her expertise spans global quality systems, regulatory strategy, inspection readiness, remediation programs, and end-to-end product lifecycle quality across GxP environments.

Ms. Gorecki has extensive experience working with global regulatory authorities, including the FDA, EMA, MHRA, Health Canada, and other international agencies, and has successfully led FDA inspections, pre-approval inspections, and multiple Warning Letter remediation efforts. She has served as an Authorized Official for biological products and has deep expertise across combination products, biologics, pharmaceuticals, and medical devices. Throughout her career, she has guided organizations through complex regulatory challenges, including large-scale remediation programs, quality system transformations, and compliance strategy development in highly regulated environments.

She previously held executive leadership roles at Johnson & Johnson, including Vice President of Global Business Quality for Janssen Pharmaceuticals, where she was responsible for global commercial quality strategy and end-to-end oversight of product quality and compliance across international markets. In prior roles, she led quality and compliance programs across North America, overseeing multiple manufacturing sites, external partners, and global supply chains, while driving significant improvements in compliance performance, product quality, and operational efficiency.

With deep expertise in quality system design, regulatory governance, and organizational transformation, Teresa has led enterprise-wide quality initiatives, including the development of cross-sector quality governance models and large-scale ERP and supply chain transformations. She brings a strategic and execution-focused approach to helping organizations strengthen compliance frameworks, improve inspection readiness, and achieve sustainable operational excellence across global operations.