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
