Senior Specialist or Manager, Quality Systems

Role: Manage Kymera's Quality Management System infrastructure, focusing on document control, training programs, and compliance monitoring to support GxP operations during late-stage development and commercialization of targeted protein degraders. Responsibilities: administer and maintain electronic QMS (Veeva Vault), oversee document lifecycle including review, approval, archiving, and biennial updates, develop and track GxP training curricula, and monitor QMS metrics for executive reporting. Support SOP development, vendor qualification, and continuous improvement of quality infrastructure. Requirements: Bachelor's in Life Sciences or related field; 5+ years in Quality Systems, document control, or GxP environment within sponsor organizations; hands-on experience with electronic QMS platforms, GxP training management, and familiarity with 21 CFR Part 11, ICH E6(R3). Preferred: experience supporting regulatory inspections, knowledge of CAPA, deviations, audits, and vendor qualification. High-value: focus on GxP compliance, document control, training management, late-stage clinical development, and commercialization activities within a biotech innovator deploying targeted protein degradation therapies. WorkSetup: not specified.