Gcp/gvp Quality Manager

vor 7 Stunden


Basel, Schweiz CTC Resourcing Solutions Vollzeit

**_The Life Science Career Network
- **

**GCP/GVP Quality Manager**

Our client, an innovative Swiss pharmaceutical company focused on the development and commercialization of innovative medicines in the field of Neurology and Pulmonology, is looking for a GCP/GVP Quality Manager for a 12-month contract based in the Basel area.

**Main Responsibilities**:

- Take responsibility over timely planning and execution of risked based internal and external GCP/GVP audit programs;
- Conduct internal and external GCP and GVP audits and manage related activities including: managing internal process, managing external vendors and clinical investigator sites, determining compliance status and identify compliance risks;
- Support GCP/GVP Inspection Readiness activities and GCP/GVP Inspections;
- Lead effective communication regarding all aspects of GCP/GVP and inspection readiness;
- Monitor and reinforce timely completion of corrective and preventive actions related to GCP/GVP issues, support and contribute to the establishment and revision of GCP/GVP Quality documents.

**Qualifications and Experience**:

- Minimum 5-7 years of experience in the Pharmaceutical/Life Science Industry;
- Good knowledge of US FDA, EU and ICH regulatory requirements and guidelines applicable to clinical research and development Pharmacovigilance Legislation;
- Extensive experience in internal and external GCP/GVP auditing and knowledge of Quality Management Systems;
- Experience with managing GCP/GVP Health authority inspections and with Inspection Readiness;
- Willingness to ravel up to 30%;
- Relevant working/residency permit or Swiss/EU-Citizenship required.


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