Summary
Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
About the Role
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.
Essential Requirements:
- Good understanding of GxP, Quality Operations and Quality Compliance requirements.
- Experience 5-7 years.
- Hands-on experience with deviations/quality events, investigations and CAPA.
- Experience creating/reviewing SOPs and other GxP/quality documentation.
- Experience supporting audits, inspections and compliance activities.
- Ability to work with quality systems/tools, generate reports and track quality metrics.
- Strong attention to accuracy, compliance, ownership and timely delivery.
- Ability to effectively communicate and collaborate with cross-functional stakeholders and business partners.
Desirable Requirements:
- Experience with APQR, QAA, QRA, KQI reporting and Self-Inspection planning.
- Exposure to supplier/vendor quality management, supplier audits and Approved Supplier Lists.
- Experience with 1QEM / Quality Event Management and Quality Analytics tools.
- Exposure to GMP external audits, Health Authority inspections and supply-chain quality.
- Experience managing SharePoint, quality repositories, trackers and document archival.
- Exposure to Quality Management Review metrics/reporting and continuous improvement initiatives.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
