GCP Compliance Manager, TMo

Apr 11, 2021

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
• Site Quality Check (site QC)
- Work with CSM groups to develop country annual site Quality Check plan, by identifying priority trials and sites with high risk.
- Prior to site QC visit, have meeting with CSM and site CRA to discuss trial protocol and site status. Conduct off-site check for CRA training records and c/s-TMF.
- During site QC, check Investigator Site Folder, trial records and source documents, IMP and sample management, and etc. And document all GCP compliance observations.
- Discuss with CSM and site CRA about all GCP compliance observations.
- Discuss with investigators if any observations are related to the investigator responsibilities.
- Draft QC report and send to CSM and site CRA for responding with action plan (CAPA).
- Discuss with CSM and site CRA to finalize the CAPA and QC report.
• Inspection Preparation
- Support CSMs to conduct site QC for inspection preparation
- Provide results to CSMs, and support action plan development and risk assessment
- Provide on-site support during inspection, and support CAPA development after inspection
• Process compliance check (process QC)
- Work with regional Process Control Manager and process SME to develop country annual process compliance check plan, by identifying processes with high risk.
- Conduct process QC by reviewing related records against requirements of SOP and/or regulations to assess the process compliance status
- Complete process QC report; provide feedback on process compliance and enhance process implementation
• Perform trend analysis of identified quality and process compliance observations.
• Provide advice on CAPA generation for QC/audit/inspection, and follow up the action owner to ensure CAPA completeness.
• Provide quality related training to TMO associates.
• Lead quality improvement initiatives.
• (when applicable) Provide support on team management of GCP Compliance associates.

Job Sourcing Statement

You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.

Minimum Requirements

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Global Drug Development
Research & Development
Full Time

GCP Compliance Manager, TMo

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