CQA Manager, Senior CQA Manager

CK QLS are recruiting for a CQA Manager, Senior CQA Manager to join a pharmaceutical company at their site based in Allschwil, Switzerland on a contract basis for 12 months.

The Role:

The main purpose of the role will be to:

• Work closely with CRO Clinical Trial Teams during the preparation, execution and closure of clinical trials.
• Support CRO Clinical Trial Teams in staying compliant with regulatory requirements (e.g., answering questions; participating to meeting to discuss GCP issues). 
• Escalate serious / continuing non-compliance GxP issues as appropriate/necessary provide / Deliver Training / Presentations.

• Contributing to ensure Quality System documents (e.g., SOP, WIS) creation and management is done in accordance with clinical trial requirements 
• Participating in the management of GCP inspections (e.g., preparation, follow up) by (international) regulatory authorities 
• Facilitating the GCP inspection CAPAs elaboration, approval, and follow-up CQA Audit for CQA manager expected to be also an Auditor 

To succeed in this role, you will come from a Life sciences, healthcare or related discipline in your undergraduate degree background  

• Good knowledge of clinical trial regulatory requirements and pharmaceutical industry practices, particularly ICH-GCP.
• Proven experience within pharmaceutical industry/health authority with experience in Quality Assurance (QA) within the ICH-GCP environment. 
• Expected to be an Auditor with the ability to travel up to 25% of the time. 

• EU/EFTA Citizen or valid Swiss work Permit.

Please quote job reference T56805 in all correspondence.