Director, Clinical Quality Program Lead (Hybrid)

Job description

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...