Global Quality Systems & Compliance Lead

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. Identify gaps and mitigate tasks.
• 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