Job Description
When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Overview 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. Job Responsibilities: Third Party Quality & Risk Management Identify, evaluate and respond to GCP quality risks related to vendor and site engagement Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings Provide quality oversight reports to appropriate sponsor's management / functions Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties Validate, monitor
