CQA Manager, Senior CQA Manager

  • Salary: Up to CHF86.44 phr
  • REF Number: v-99261
  • Consultant: Hendre Moolman
  • Contact: 01438842970
  • Date Published: 09.04.2024
  • Industry: Pharmaceutical
  • Location: Allschwil, Switzerland
  • Functional Expertise: Clinical Operations/Development

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.
Further responsibilities will include:

  • 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 
Your Background:

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. 
Right to work requirement for Switzerland:

  • EU/EFTA Citizen or valid Swiss work Permit.

Please quote job reference T56805 in all correspondence.

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