Tommy Madden serves as the Senior Director of GMP Quality at Prothena Corporation plc, where he plays a pivotal role in ensuring the integrity and compliance of the company’s worldwide clinical programs. With over 20 years of experience in the Pharmaceutical, Medical Device, and Biotechnology...
Tommy Madden serves as the Senior Director of GMP Quality at Prothena Corporation plc, where he plays a pivotal role in ensuring the integrity and compliance of the company’s worldwide clinical programs. With over 20 years of experience in the Pharmaceutical, Medical Device, and Biotechnology sectors, Tommy has cultivated a robust expertise in Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), which are essential for maintaining the highest standards of quality in drug development and clinical trials. His leadership is characterized by a commitment to fostering dynamic teams, empowering them to achieve successful business outcomes while navigating the complexities of regulatory compliance.
At Prothena, Tommy is at the forefront of key projects that involve rigorous auditing processes and product reviews, ensuring that all operations align with both internal quality metrics and external regulatory requirements. His strategic oversight of batch processing and quality operations not only supports the company’s clinical development initiatives but also enhances the overall efficiency of biopharmaceutical production. By leveraging his extensive background in pharmaceuticals and biopharmaceuticals, he effectively drives initiatives that improve operational excellence and product quality.
Tommy’s ability to coach and mentor teams has been instrumental in building a culture of continuous improvement within the organization. His focus on key metrics and performance indicators allows Prothena to maintain a proactive approach to quality assurance, ultimately contributing to the successful advancement of innovative therapies. As the landscape of drug development continues to evolve, Tommy’s insights and leadership will remain critical in navigating the challenges and opportunities that lie ahead in the biopharmaceutical industry.
