Development Quality Manager (m/f/d)

REFERENCE NUMBER:

597476/1

MY DUTIES:

- Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance (PV) related audits
- Provide support prior to, during and after health authority (HA) inspections within the country organization and at investigational sites
- Ensure that responses to local HA have been submitted, commitments have been met and relevant actions plans have been completed/closed
- Ensure that deviations and issues are properly managed in the internal tracking system including the respect of the escalation process
- Support the investigation process (root cause analysis, action plan development) as appropriate
- Management of vendors in the GCP / PV area as well as for Patient Oriented Programs (POPs)
- Perform (re-)qualification of vendors in the GCP / PV area as well as for external service providers involved in Patient Oriented Programs (POPs)
- Perform the release of Investigational Medicinal Products for clinical trials, investigator-initiated trials and managed access programs
- Ensure that all IMP release-related documents are filed in the related database
- Keep oversight of release activities
- Support the implementation of global SOPs to local Quality Management System
- Review and update local SOPs, Working Practices and Forms

MY QUALIFICATIONS:

- Degree in Life Sciences or related fields
- Languages: English fluent in speaking and writing AND basic German language skills
- Experience in the pharmaceutical industry with focus on pharmacovigilance, QA or GCP Additional Requirements
- Strong project management skills
- Stakeholder management skills and strong communication skills
- Sense of urgency
- GCP and PV Knowledge

MY BENEFITS:

- Flexible hours in a renowned pharma company
- Pleasant working atmosphere
- Challenging and varied tasks in a promising and innovative industry
- Contract extension possible

ABOUT HAYS:

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
Chiara Milan

Reference number
597476/1

Contact
E-Mail: [email protected]