Associate Director, Clinical Quality Assurance

Playing a critical hands-on role within Kailera, the Associate Director, Clinical Quality Assurance will be relied upon as subject matter expert in GCP and GVP compliance with respect to the planning, document review, execution, and close-out of Clinical Studies and related drug safety. Responsible to collaborate/support with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, Biometrics, and Clinical Pharmacology and other departments on the implementation of Risk Based Quality Management within assigned program(s); identifying and evaluating the remediation of fundamental risks and quality issues internally, at vendors and clinical sites; and collaborating with stakeholders to ensure inspection readiness for assigned programs, laying the foundation for successful outcomes during submission-related and unannounced inspections. This role will involve ongoing interaction with internal project team members as well as with vendors, partners, and project teams, influencing these internal and external stakeholders to successfully embed a strong quality culture.