Global Quality Systems & Compliance Lead

Our Work Matters: We make products that save lives, ensuring better health and well-being for patients around the world. The Global Quality Systems & Compliance Lead is responsible for driving strategic initiatives that enhance global quality through innovation, compliance, and harmonization. Requirements - Drive adoption of innovative technologies and digital solutions to improve quality processes. - Develop and maintain global SOPs and policies for quality. - Ensure compliance with international regulatory requirements (FDA, EMA, ISO, etc.). - Establish governance frameworks for data integrity across global operations. - Identify and implement process optimization opportunities. - Collect, standardize, and disseminate best practices across global sites. - Manage the Quarterly Management Review process across the organization - Develop Quality Management Maturity Models (QMM) for each quality system and track measurements, work with Systems to implement improvements - Develop and execute a comprehensive regulatory compliance strategy aligned with business objectives. - Issue and track regulation changes and how they impact each of the locations. - Create a culture and have discussions related to near misses during inspections/audits - Foster a culture of compliance and ethical business practices - Creation and management of inspection management tools - Create and manage Inspection Readiness program including scoring metrics - Develop and deliver training content for global quality and inspection management/compliance topics. - Facilitate knowledge-sharing forums and communities of practice. - Lead compliance training, programs for employees and management