As the Director of Computer System Validation at TrialSpark, Joseph Machi plays a pivotal role in ensuring that the company's regulatory and compliance systems meet the stringent requirements of the pharmaceutical and biotechnology sectors. With a robust background in Good Clinical Practice (GCP) and a...
As the Director of Computer System Validation at TrialSpark, Joseph Machi plays a pivotal role in ensuring that the company's regulatory and compliance systems meet the stringent requirements of the pharmaceutical and biotechnology sectors. With a robust background in Good Clinical Practice (GCP) and a deep understanding of validation processes, Joseph is responsible for overseeing the Validation Program that encompasses all regulated products and critical systems. His expertise in managing complex validation projects is complemented by his proficiency in Laboratory Information Management Systems (LIMS) and Clinical Trial Management Systems (CTMS), which are essential for maintaining data integrity and compliance throughout the clinical development lifecycle.
Joseph's leadership is characterized by his ability to assemble and guide high-performing teams, fostering a culture of excellence and accountability. He collaborates closely with functional operations and engineering leads to ensure that the selection, commissioning, qualification, and validation of systems and processes align with industry standards and Good Manufacturing Practices (GxP). His strategic approach not only enhances operational efficiency but also mitigates risks associated with regulatory compliance.
In addition to his technical skills, Joseph is adept at conducting audits and implementing standard operating procedures that streamline validation processes. His commitment to continuous improvement and technology transfer ensures that TrialSpark remains at the forefront of innovation in clinical research. By leveraging his extensive knowledge of ISO standards and FDA regulations, Joseph is instrumental in driving the company's mission to accelerate the development of life-saving therapies while maintaining the highest levels of quality and compliance.
