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Associate Director, Clinical Quality

AstraZeneca · Durham, North Carolina, US

Location: Durham, NC 3 Days in office/week The role is responsible for supporting quality partnering across BioPharmaceuticals R&D, providing data-driven ins...

Job description

Location: Durham, NC 3 Days in office/week The role is responsible for supporting quality partnering across BioPharmaceuticals R&D, providing data-driven insights to inspection readiness, regulatory compliance, and empowering study teams to deliver clinical studies. The Associate Director, Clinical Quality is responsible for facilitating the delivery of Quality Management activities related to Clinical Operations within R&D working with partners across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities. They are also accountable for identifying and sharing industry trends in quality for the new business area(s), in their scope, through benchmarking with industry peers, and collectively developing compliance focussed improvements to R&D processes. Responsibilities: Establish and maintain effective systems and processes to support key performance areas for the function & wider organisation to maintain Quality Management excellence. Work closely with colleagues and collaborators to support quality assurance and regulatory adherence initiatives. Promote a culture of quality across R&D as a quality champion. Provide advi...