Senior Clinical QA Manager

For one of our clients in Basel we are looking for a Senior Clinical QA Manager.

  • Do you have a degree in life sciences?
  • Do you really enjoy working in cross functional teams?
  • Do you have excellent oral and written communication skills in English?

Then you might be the candidate we are looking for! Don't hesitate to apply now!

Responsibilities 
Work as per the defined strategy for the global clinical audit program (e.g. site, vendor, process)
Plan, perform, and report audits (e.g. site, vendor, process) using considerable latitude in determining best practice and approach
Develop own area of ICH-GCP expertise with limited supervision (e.g. self-training, knowledge acquisition by reading/assisting to course identify by himself) 
Lead the preparation, facilitation and follow up of inspections by national and international regulatory authorities
Facilitate the CAPAs elaboration and follow-up
Escalate serious / continuing non-compliance issues as appropriate
Make a significant contribution to ensure that QS documents creation and management is done in accordance with ICH-GCP requirements / regulations
Contribute to process improvements and trouble shooting
Maintain awareness / expertise in international ICH-GCP requirements
Provide leadership and direction on ICH-GCP related activities / issues
Work closely with internal / CRO Clinical Trial Teams
Support internal / CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical Quality Management System and clinical trial framework by different ways (e.g. provide training to CD staff, feedback to ICH-GCP questions)
Highly contribute to develop/improve CQA tools and processes
Represent CQA in internal and external meetings and particularly represent Team Leader CQA when he/she is not available
Perform any other CQA task that could help to achieve a high adherence to ICH-GCP requirements
 
 
Profile 
  • Degree in (life) sciences or healthcare
  • Experienced in Clinical Research & Development. At least 6 years of experience in pharmaceutical industry/health authority with at least 3 years of experience in Quality Assurance / Auditing (QA) within the ICH-GCP environment.
  • In-depth knowledge of global ICH-GCP requirements and pharmaceutical industry practices
  • Ability to work as a team player and independently
  • Reliable, conscientious, agile/flexible
  • Proven record of excellent problem solving, risk analysis and negotiation skills
  • Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource)
  • Experience in medical device and/or combination product will be an added value
  • Strong writing, communication and listening skills
  • Experience in international cross-cultural relations
  • Very good English knowledge (written and spoken)
Contact Information 

Ulrike De Smedt

+32 15 21 11 04

ulrike.desmedt@valesta.com

Application form : Senior Clinical QA Manager

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