Development Quality Manager
Posted on Mar 12, 2020 by Harvey Nash IT Recruitment Switzerland
For our client in Rotkreuz we are looking for a Development Quality Manager for a 12 months contract.
Job Title: Development Quality Manager
The Development Quality Manager is 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 Quality Management System in the Country Organization to achieve a high level of quality and compliance.
- Audit management:
o Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance (PV) related audits.
- Inspection management:
o Provide support prior to, during and after health authority (HA) inspections within country organization and at investigational sites.
o Ensure that responses to local HA have been submitted, commitments have been met and relevant actions plans have been completed/closed.
- Deviations and Issues Management:
o Ensure that deviations and issues are properly managed in the internal tracking system including the respect of the escalation process.
o 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):
o Perform (re-)qualification of vendors in the GCP/PV area as well as for external service providers involved in Patient Oriented Programs (POPs).
- Release activities:
o Perform the release of Investigational Medicinal Products for clinical trials, investigator-initiated trials and managed access programs.
o Ensure that all IMP release-related documents are filed in the related database.
o Keep oversight of release activities.
- SOP Management:
o Support the implementation of global SOPs to local Quality Management System.
o Review and update local SOPs, Working Practices and Forms.
Education: Degree in Life Sciences or related fields
Languages: MUST HAVE: English fluent in speaking and writing AND basic German language skills, OPTIONAL: other languages are an asset
Experience: Min. 3-5 years' experience in the pharmaceutical industry with focus on pharmacovigilance, QA or GCP
- MUST HAVE: Strong project management skills
- MUST HAVE: Stakeholder management skills and strong communication skills
- MUST HAVE: sense of urgency
- GCP and PV Knowledge
For more information please contact Barbara Tenerowicz:
E: (see below)