Director,ClinicalQualityProgramLead

**Job Description** **General/Position Summary** The Director, Clinical Quality Program Lead (CQPL) is responsible for the quality oversight across a range of study phases within assigned disease area(s) to ensure that trials are conducted in accordance with GCP requirements. The CQPL has oversight of real-time inspection readiness, risk management and quality health of programs in their assigned disease area(s). This position reports directly to the Senior Director of Global Clinical Quality (GCQ) and will sit on the GCQ Leadership Team. This position will have line management responsibilities. **Key Duties & Responsibilities** * Partner with business stakeholders across Global Clinical Operations, Clinical Development, Regulatory, etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness * Proactively identifies risks to quality and assists with implementation of mitigations/contingency plans, providing regular updates to the R&D Quality Leadership Team and other cross-functional stakeholders at various levels * Collaborates cross-functionally, to oversee and support the quality of all clinical trials within assigned disease areas, ensuring a focus on risk management and inspection readiness throughout * Provides oversight to development, execution and continual improvement of quality risk management/mitigation and inspection readiness strategies across assigned disease areas in collaboration with cross-functional stakeholders in R&D Quality, Global Clinical Operations, etc. * Provides leadership and guidance to implementation of risk-based approaches to quality for clinical development program(s) – e.g. Quality by Design principles, and ensure effectiveness of mechanisms for ongoing quality risk monitoring, mitigation and management * Contributes to the strategic evolution of GCQ pillar, including development of key processes and departmental goals/objectives. * Collaborates within RDQ to ensu