Hobson Prior is working with a Swiss clinical stage biopharmaceutical company focused on advancing modern medicine and improving the management of serious diseases. Our client is looking for a highly motivated Clinical QA Manager. The QA Manager will be responsible for quality assurance, with respect to clinical development activities in compliance with GCP, applicable regulatory requirements and corporate procedures.
- Establish and review the quality/clinical documents and processes and whilst maintaining the archive for long-term storage of regulated documents.
- Participate in the maintenance and continuous development of the Quality System.
- Set-up, maintain and manage the CAPA system to ensure timely remediation of quality incidents identified at the company’s clinical sites and vendors, e.g. during monitoring, audits or inspections.
- Give project team guidance on GCP, GCLP and applicable regulations (e.g. clinical operations, medical/safety, project leaders, bioanalytics, IT, etc.).
- GXP compliance of computerized system validation/qualification and change control according to GAMP5 and 21CFR11.
- Follow-up of non-compliance to the Quality System and applicable regulations in an effective way.
- Maintaining a GCLP laboratory and support the implementation.
- Identify trends and changes for areas of improvement within regulations, guidelines, and recommendations.
- Pragmatic problem-solving capabilities
- Strong analytical skills and attention to detail
- Team orientated, strong service delivery focus
- Excellent verbal and written communication skills
- Clinical quality function experience – minimum of 5 years
- In depth knowledge of GCP, good understanding of the legal and regulatory framework around GXP
- Involvement in running clinical trials in EU and US
- Experience in performing audits
- Life Science’s degree
- Working knowledge of GCLP and GMP would be an advantage
- Fluent in verbal and written German and English
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.