Central Monitoring Manager
PSI CRO AG
Development Quality Manager – Pharma
Novartis
full-time
Posted on:
Location: 🇵🇱 Poland
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Assure quality oversight of activities in all Novartis entities in-country to ensure compliance with GCP and GPvP
- Collaborate with Study and Site Operations, Patient Safety, Regulatory Affairs, Medical Affairs, NCQ & Commercial teams for patient-facing projects
- Ensure implementation of Novartis Quality Manual and Quality Management System locally
- Oversee implementation, maintenance, and monitoring of local Quality System and Quality Plan
- Ensure training systems for GCP, GPvP and relevant Development activities are in place
- Monitor local Quality System, processes and Key Quality Indicators to identify quality risks and address them
- Partner with local and global Development teams on quality issues and audits; ensure CAPAs are implemented
- Provide leadership and support for GCP and GPvP Health Authority inspections and timely responses
- Execute QA activities for qualification and governance of third party activities with clinical/medical or PV component
Requirements
- Degree in Life Sciences or related fields
- Solid experience in the pharmaceutical industry in quality assurance, regulatory affairs, pharmacovigilance or directly related area
- Ideally several years of experience in clinical development
- Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines
- Excellent verbal and written communication skills
- Proven track record in leading projects and stakeholder management
- Full professional proficiency in English
- Native proficiency in Polish and/or Romanian
