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 Originally posted on Himalayas