摘要
Location: Amsterdam, The Netherlands
The Development Quality Assurance Manager is responsible for assuring quality oversight of activities undertaken in all Novartis entities in a country to ensure they are conducted in compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines.
Operates in direct collaboration with local Development colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs), Medical Affairs, Novartis Country Quality (NCQ) & Commercial teams for patient-facing projects, products and programs. Ensures implementation of the Novartis Quality Manual and Quality Management System in the country to achieve a high level of quality and compliance.
About the Role
Key responsibilities:
- Oversee implementation, maintenance, and monitoring of the local Quality System and Quality Plan to ensure compliance with Novartis global requirements and applicable local regulations.
- Ensure adequate training systems are in place for GCP, GPvP, and other relevant Development activities.
- Monitor local Quality System, processes, and Key Quality Indicators (KQIs) to proactively identify potential quality risks and collaborate with business partners to address them.
- Partner with local and global Development teams in the execution and follow-up of quality issues and audits related to clinical development and PV activities, ensuring robust corrective and preventive actions are implemented.
- Provide leadership and support for GCP and GPvP Health Authority (HA) inspections, ensuring timely submission of responses to local HA and completion of CAPAs.
- Execute QA activities required for the qualification and monitoring/governance of third party activities with a clinical/medical or PV component.
Essential Requirements:
- Typically more than 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance or a directly related area, preferably with a minimum of 3 years experience in clinical development.
- Dutch and English language
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
