Quality Compliance Lead - Novartis
Indianapolis, IN
About the Job
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Quality professionals to help us reach our ambitious goals.
The Quality Compliance Lead will provide regulatory compliance awareness, education, and guidance to the different functional areas on how to interpret, understand and comply with the regulation requirements and expectations including GMP and industry practices. In this role you will be responsible for overseeing and supporting the Inspection Audit Program, Customer Complaint Reporting, Supplier Qualification Program, Annual Product Quality Review, Health Authority Notifications & Market Actions, and Escalation Management.
Your responsibilities include, but are not limited to:
• Contributes to the design architecture of Quality Compliance by authoring or providing robust compliance feedback to the procedures governing the site compliance programs and working with other functional departments towards their timely implementation.
• Supports the site level Quality Management Review program including monitoring and reporting key performance indicators, as appropriate.
• Works with the management team to implement and execute the Inspection Readiness program, including Novartis Corporate Inspections and Global Health Authority Inspections.
• Supports quality inspections at the site level.
• Monitors industry observations and trends as a preventive tool to ensure compliance.
• Develops internal audit schedule and lead internal audit performance, follow up, and escalation of significant observations.
• Supports management to implement and maintain the following programs: Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments
• Leads and prioritize on-going continuous improvement projects directly related to Quality Compliance to support business needs.
• Reviews and approve global change controls, deviations and CAPA and perform effectiveness checks.
• Acts as representative in monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
The Quality Compliance Lead will provide regulatory compliance awareness, education, and guidance to the different functional areas on how to interpret, understand and comply with the regulation requirements and expectations including GMP and industry practices. In this role you will be responsible for overseeing and supporting the Inspection Audit Program, Customer Complaint Reporting, Supplier Qualification Program, Annual Product Quality Review, Health Authority Notifications & Market Actions, and Escalation Management.
Your responsibilities include, but are not limited to:
• Contributes to the design architecture of Quality Compliance by authoring or providing robust compliance feedback to the procedures governing the site compliance programs and working with other functional departments towards their timely implementation.
• Supports the site level Quality Management Review program including monitoring and reporting key performance indicators, as appropriate.
• Works with the management team to implement and execute the Inspection Readiness program, including Novartis Corporate Inspections and Global Health Authority Inspections.
• Supports quality inspections at the site level.
• Monitors industry observations and trends as a preventive tool to ensure compliance.
• Develops internal audit schedule and lead internal audit performance, follow up, and escalation of significant observations.
• Supports management to implement and maintain the following programs: Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments
• Leads and prioritize on-going continuous improvement projects directly related to Quality Compliance to support business needs.
• Reviews and approve global change controls, deviations and CAPA and perform effectiveness checks.
• Acts as representative in monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
Source : Novartis