Samuel Manoranjan

About Samuel Manoranjan

A result driven, strategic thinker capable of solving complex problems using sound…

Experience

1. Vice President of Quality

   Stoke Therapeutics

   Feb 2023 — Present

   Reporting into the Chief Regulatory Officer, responsible for building from ground up and leading Stoke’s Quality department in all GXP functional areas to ensure compliance in the manufacture and testing of product and conduct of study for nonclinical and clinical evaluations of Stoke’s therapeutic products. Responsible for collaborating with the GXP functional areas to facilitate quality and compliance in all GXP-related activities through the establishment of essential internal quality policies, processes, and procedures and towards establishing a culture of quality. Responsible for setting quality strategies for quality governance and operations to ensure compliance to GXP regulatory requirements and for developing short and long-term plans to achieve both quality and business objectives. Responsible for providing tactical, operational, and strategic quality leadership related to CGMP operations at CMOs/ CTLs and CMC deliverables for product development. Responsible for GLP/ GCP compliance at CROs/ partners, including vendor selection and qualification, study setup, protocol development, protocol deviations, safety monitoring, study conduct, study conclusion reporting. Oversee Quality Control function responsible for product release testing, Stability management, Reference Standard management, specifications and analytical method validation. Oversee Computer Systems Validation (CSV) for GXP IT systems and software implementation at Stoke.