Quality Strategy and Leadership

Develop and implement a comprehensive quality assurance (QA) strategy for product development activities. Align QA processes with organizational goals, regulatory requirements, and industry standards. Drive initiatives to improve QA processes in product development, ensuring efficiency and compliance. Collaborate with R&D, manufacturing, regulatory, and clinical teams to integrate quality principles into development activities. Serve as a subject matter expert on QA in development, providing guidance to cross-functional teams.

Regulatory Compliance  Ensure all development processes comply with relevant regulations (e.g., FDA, EMA, ISO, ICH guidelines).Stay updated on industry trends, regulatory changes, and best practices to enhance the organization’s QA framework. Ensure compliance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Pract...