Senior Clinical Quality Assurance Manager

vor 4 Wochen

Bern, Schweiz Pharmiweb Vollzeit

RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Senior Clinical Quality Assurance Manager on a 12 month contract in Switzerland. This company discovers, develops, and commercializes medicines across a wide variety of therapeutic areas.

This role will be a 12 month, 1 FTE contract and it will be hybrid working - a mix of home working and office based in Allschwil. The hourly rate on offer is in the range CHF 69.49 - 86.44 DOE.

Responsibilities

  • To work closely with CRO Clinical Trial Teams during the preparation, execution and closure of clinical trials
  • To develop his own area of clinical trial expertise with limited supervision (e.g., self-training, knowledge acquisition by reading/assisting to course identified by himself)
  • To ensure  CRO Clinical Trial Teams stay compliant with regulatory requirements (e.g., answering questions; participating to meeting to discuss GCP issues)
  • To influence and convince CRO Clinical Trial Teams to implement robust clinical trial processes / systems
  • To escalate serious / continuing non-compliance GxP issues as appropriate/necessary
  • To organize trainings on clinical trial requirements (e.g., ICH-GCP refresher)
  • To present ICH-GCP important topics (e.g., CQA audit finding, GCP inspection)
  • To contribute in training / mentoring other CQA colleagues Quality Systems
  • To manage Quality System documents (e.g., SOP, WIS) creation and management and to ensure it is done in accordance with clinical trial requirements
  • To manage/lead process improvements
  • To develop/improve CQA tools and processes
  • To develop/improve clinical trial electronic systems (e.g., Quality Event Module, clinical trial systems)
  • To help with trouble shooting processes and systems GCP Inspection
  • To lead/manage the preparation, facilitation and follow up of inspections by international regulatory authorities
  • To lead/manage GCP inspection CAPAs elaboration, approval and follow-up CQA Audit for CQA manager expected to be also an Auditor
  • To work as per the defined strategy for the global clinical audit program (e.g., site, vendor, process)
  • To plan, perform, and report standards and/or complex audits (e.g., site, vendor, process) at the global level
  • To lead/manage CAPAs elaboration, follow-up and closure

Experience

  • At least a bachelor’s degree or equivalent education/degree in (life) sciences or healthcare
  • Experienced in Clinical Research & Development
  • Good knowledge of clinical trial regulatory requirements and pharmaceutical industry practices - particularly ICH-GCP 
  • At least 6 years of experience within pharmaceutical industry/health authority with at least 3 years’ experience in Quality Assurance (QA) within the ICH-GCP environment
  • Knowledge of electronic tools used in clinical trials (e.g., eTMF, ePRO, eSource)
  • Reliable, conscientious, agile/flexible, open-minded 
  • Very good risk analysis and problem-solving skills
  • Very good negotiation skills
  • Very good writing, verbal and listening skills
  • Ability to work as a team player and independently
  • Experience working in international cross-cultural relations
  • For Senior CQA manager expected to be also an Auditor: ability to travel at least 25% of the time

Please apply here and Harry Henson will be in touch to discuss your application in more detail.

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