Specialist, Quality Operations

Job Description Summary About the role: Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. Job Description Key Requirements: Deliver Quality Operations and Quality Compliance activities in line with GxP, regulatory requirements, internal quality standards and SOPs. Manage and support quality documentation , including SOPs, working procedures, process maps, trend reports, qualification reports and technical investigations. Support deviations, quality events, investigations and CAPA management , including tracking, trending and timely closure. Support internal/external audits, inspections, self-inspections and supplier audit activities . Manage quality-related activities across APQR, QAA, QRA, KQI metrics and Approved Supplier Lists . Support vendor/supplier quality management , including supplier onboarding, assessments, agreements and monitoring. Generate and analyze quality metrics and reports using approved systems/tools and ensure accurate, timely deliverables. Maintain quality records, trackers, SharePoint content and relevant documentation. Partner effectively with internal stakeholders, customers and business partners while supporting continuous process improvement.