Associate Director/Director, Quality
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About The Position
The Associate Director /Director R&D Quality Assurance will oversee the execution of Non-Clinical and Clinical Quality Assurance activities across the Aditum Bio portfolio companies, ensuring activities align with GLP and GCP expectations and the Quality Management System, and works closely with internal and external colleagues to develop systems and processes in-line with regulatory requirements, GCP, GLP, and internal quality processes, as applicable. This role will also support GxP internal, external, and supplier audits in accordance with international GxP requirements and Aditum Bio standards. The role is responsible for working cross-functionally with stakeholders across the business to support the escalation and management of Deviations, Corrective and Preventive Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes. Additionally, the Associate Director/Director will serve as Quality Lead across non-clinical and clinical programs. They will be responsible for providing quality oversight across GLP and clinical activities throughout start-up, maintenance and close out. The ideal candidate will actively partner with the functions to identify and work on solutions to improve quality. They will leverage his/her experience, understanding of GxP, and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GxP, and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.
