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.

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.

 

Skills Desired

Collaboration, Communication, Data Integrity, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)