Jul 14, 2022

Job Description

124! Is the number of clinical trials currently ongoing in the Netherlands! Take a chance and get the opportunity to work with us to ensure quality and continuous improvement within the area of Good Clinical Practice and Pharmacovigilance.

The Development Quality Assurance Manager is responsible for assuring quality over-sight for activities undertaken in all Novartis entities in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines to assure the execution of high quality research and activities. Activities in scope include but may not be limited to assuring adequate systems are in place for the protection of patient safety, rights and well-being, data integrity, oversight of local Investigational Medicinal Product (IMP) release, and quality oversight of Clinical and Pharmacovigilance activities as needed in both pre- and post- market settings in assigned country(ies) in all Novartis entities.

The Development Quality Assurance Manager is responsible for assuring the quality and compliance of Global Drug Development (GDD), Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local GDD colleagues (Trial Monitoring Operations, Patient Safety and Regulatory Affairs), Medical Affairs and Country QA to ensure compliance to Novartis entities requirements and relevant HA regulations and guidance. Ensures implementation of the Novartis Quality Manual and Quality Management System in assigned country(ies) to achieve a high level of quality and compliance.

Major accountabilities:

- Local Quality System
- Quality Plan and Continuous Improvement
- Training systems
- Quality Issue Management
- Risk Identification and Management
- Inspection Management and Support
- Audit Management
- CAPA management
- ESP/Supplier Management
- Data integrity
- Governance/Communication

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

- Degree in Life Sciences or related fields
- English fluent in speaking and writing
- 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
- Experience in leading projects
Global Drug Development
Full Time
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Development Quality Assurance Manager

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