Will Supervise a team of Complaint Specialists in completing and documenting investigations on customer complaints for products manufactured and/or packaged at by External Contractors/ Third Party Organizations managed by the Novartis Consumer Health US TPO QA organization.
Manage and monitor the complaint team’s performance to ensure all complaint investigations are completed in accordance with Novartis and GMP requirements. Foster continuous improvement through analysis of the complaints process and implement efficiencies when identified.
• Manage the TPO complaint handling processes and ensure that all product quality complaints are adequately investigated, reported and any follow up activities initiated in compliance with the Novartis Quality Manual and regulatory and legislative requirements
• Liaise with the US TPO QA Operations Team as well as the off-site Complaints Call Center, and may interact with outside clients
• Liaise with the US TPO Compliance team to support evaluations of critical complaints and Field Alert Assessments
• Liaise with the US TPO Quality Systems team to ensure complaint metrics reporting is accurate and on time
• Manage Complaints Team to ensure that complaint cases are completed on time and with high quality (right first time)
• Drive continuing improvement of the Complaints handling process
• Coordinate with US TPO Quality Operations and the TPO complaint investigators to complete all required investigations. Provide QA review and approval to formal complaint investigation reports
Bachelors Degree in a scientific, engineering, or related discipline. (Advanced degree preferred)
• 5 years experience in a regulated pharmaceutical industry environment including experience in manufacturing, analytical science, R&D, documentation , or engineering
• Demonstrated, strong working knowledge of GxP and FDA regulations
• Experience reporting with Trackwise and/or other complaints management system or other reporting system
• Experience leading and managing a small to medium-sized team of associates (including development and performance appraisal).
• Quality Assurance Complaints Handling experience a plus
Novartis - 10 months ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...