Alysha Barre serves as the Executive Director and Global Deviation Task Force Lead at Genentech/Roche, where she plays a pivotal role in enhancing the robustness of the company's global operations. With a deep-seated expertise in cGMP manufacturing and quality systems management, Alysha is at the...
Alysha Barre serves as the Executive Director and Global Deviation Task Force Lead at Genentech/Roche, where she plays a pivotal role in enhancing the robustness of the company's global operations. With a deep-seated expertise in cGMP manufacturing and quality systems management, Alysha is at the forefront of driving strategic initiatives that address both planned and unplanned deviations across the Roche network. Her leadership is characterized by a commitment to operational excellence, leveraging LEAN methodologies to foster a culture of continuous improvement and efficiency.
In her current role, Alysha is instrumental in refining the processes surrounding Root Cause Analysis (RCA), ensuring that the organization not only identifies the underlying causes of deviations but also implements sustainable solutions to eliminate recurring quality issues. Her focus on engraining effectiveness within the quality system is vital for maintaining compliance with regulatory standards, including 21 CFR Part 11, and ensuring that all operations meet stringent GMP requirements.
Alysha's expertise extends to critical areas such as Corrective and Preventive Actions (CAPA), technology transfer, and validation processes, including Computer System Validation (CSV) and Verification & Validation (V&V). Her ability to navigate complex regulatory landscapes while fostering collaboration across global teams has positioned her as a trusted leader in the biotechnology sector. Through her strategic vision and hands-on approach, Alysha is not only enhancing operational efficiencies but also cultivating an environment where quality and compliance are ingrained in the organizational culture, ultimately driving Genentech/Roche toward its mission of delivering innovative therapies to patients worldwide.
