Senior Clinical QA Manager

Location
Basel Area
Salary
Competitive
Posted
21 Nov 2018
Closes
04 Feb 2019
Ref
896076-P
Discipline
Quality, QA / QC
Contract Type
Permanent

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

Responsibilities

  • Bachelor degree or equivalent education/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
  • Proven record of excellent problem solving, risk analysis and negotiation skills;
  • Interest and knowledge of electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource);
  • Strong writing, communication and listening skills;
  • Experience in international cross-cultural relations;
  • Very good English knowledge (written and spoken);
  • Ability to travel at least 25% of the time;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

 

 

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