Third Party Quality Lead, Senior Manager - FSP

The Third Party Quality Lead (TPQL) reports to the Head of Third Party Quality. The TPQL works with stakeholders and relevant oversight teams for third party quality risk management, issues management and general Good Clinical Practice guidance. The TPQL maintains Quality-to-Quality contacts with major vendors and site entities partnering with Clinical Development & Operations (CD&O). The TPQL is responsible for assessing and ensuring that clinical trial third party partners have the appropriate quality systems infrastructure, including a culture of quality and compliance to adhere to sponsor's policies and procedures with all applicable external regulatory requirements relating to GCP including those related to patient safety, data integrity, and protocol adherence as set out in the Master Services Agreement. The TPQL the vendor engagement framework, including processes, tools, roles and sourcing strategy.