Beschreibung
Development Quality Manager (m/f/d)
Reference: -en
Start: 04/20
Duration: 12 MM
Main tasks:
- Responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and for assuring quality and compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV), as well as GxP activities related to Marketing
- Ensure in direct support, collaboration and partnership with the Clinical Studies Department, Medical Department, Patient Safety, Regulatory Affairs and Marketing Departments the implementation of the companies Quality Management System in the Country Organization to achieve a high level of quality and compliance
- Audit management: Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance (PV) related audits.
- Inspection management: Provide support prior to, during and after health authority (HA) inspections within the companies country organization and at investigational sites.
- Deviations and Issues Management: Ensure that deviations and issues are properly managed in the internal tracking system including the respect of the escalation process.
- Management of vendors in the GCP / PV area as well as for Patient Oriented Programs (POPs)
- Keep oversight of release activities - SOP ManagementStrong project management skills
Main qualifications
- Degree in Life Sciences or related fields
- English fluent in speaking and writing AND basic German language skills (OPTIONAL: other languages are an asset)
- Profound experience in the pharmaceutical industry with focus on pharmacovigilance, QA or GCP
- Stakeholder management skills and strong communication skills
- Strong project management skills
Main advantages:
- We will create a candidate profile containing your strengths and potential and thus increase your chance of being placed in a position
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Michael Andreas Ochmann
Referencenumber:
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