Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing

  • Introduction to the need for quality and compliance transformation and the impact of shifting regulatory landscapes on quality assurance and compliance
  • The role of advanced technologies in enhancing quality practices, ensuring data integrity and improved product safety and efficacy
  • Strategies for supplier quality management for maintaining consistency and building a culture of quality and compliance
  • Case studies highlighting quality driven practices that have led to improved transformation in enhancing quality practices
  • Real world success stories in transforming quality practices for the modern pharmaceutical landscape

Nicolas Maldonado
Executive Director, Global Quality Policies and Systems
Gilead Sciences

Nicolas is an executive leader and change Agent with 34 years of global, well-rounded experience in the Immunodiagnostics, Biopharmaceutical & Medical Device businesses.  He holds an outstanding record for driving successful compliance, operational excellence, and personnel development, and has led multiple large-scale projects to grow businesses and organizational capacity.

Before joining Gilead, Nicolás completed 27 years in Abbott Laboratories where he held positions of expanded leadership in Technical Support, Analytical Laboratory Operations, Regulatory Compliance, Quality Assurance Operations and Quality Systems in Puerto Rico, the continental US and in Europe, Northwest Africa and Russia.  At Gilead Sciences, Nicolas has been spearheading the Quality digital strategy, including advancing the implementations of Veeva Vault Quality Docs, QMS and RIM.  He is complementing these with a global strategy for Advanced Analytics, Data Visualization, Technology Adoption Tools and modernizing the employee learning experience.

Nicolás holds a BS degree in Biochemistry and a Masters in Microbiology Immunology from Stony Brook University and the Temple University Medical School, respectively where he completed research work in hormone biochemistry and in the immunoregulation of autoimmune diseases.