Senior Clinical QA Manager

Reference Number: 896076-W
Type of placement: Permanent
Location: Switzerland

Introduction:

CTC Resourcing Solutions, founded in Basel, Switzerland in 1997, is a specialist staffing organisation based in Basel, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing

Main 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 the client / CRO Clinical Trial Teams;
  • Support the client / 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

Qualifications and Experience:

  • 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 Idorsia / CRO Clinical Trial Teams;
  • Support Idorsia / 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

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