Clinical Quality Assurance Manager

vor 2 Monaten

Bern, Schweiz Pharmiweb Vollzeit

RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a 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 the CRO Clinical Trial Teams during the preparation, execution and closure of clinical trials
  • To support the CRO Clinical Trial Teams in staying compliant with regulatory requirements (e.g., answering questions; participating to meeting to discuss GCP issues)
  • To escalate serious / continuing non-compliance GxP issues as appropriate/necessary Provide / Deliver Training / Presentation
  • To organize and/or help with trainings on clinical trial requirements (e.g., ICHGCP refresher)
  • To organize and/or help presentation on ICH-GCP important topics (e.g., CQA audit finding, GCPinspection) 
  • To contribute ensuring Quality System documents (e.g., SOP, WIS) creation and management is done in accordance with clinical trial requirements
  • To help/contribute to process improvements
  • To help/contribute to clinical trial electronic systems (e.g., Quality Event Module, clinical trial systems)
  • To help with trouble shooting for processes and systems GCP Inspection
  • To participate in management of GCP inspections (e.g., preparation, follow up) by (international) regulatory authorities
  • To facilitate the GCP inspection CAPAs elaboration, approval, and follow-up CQA Audit
  • To work as per the defined strategy for the global clinical audit program (e.g., site, vendor, process) 
  • To plan, perform, and report standards ICH-GCP audits (e.g., trial site, vendor, process)
  • To 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 3 years of experience within pharmaceutical industry/health authority with at least 1 year experience in Quality Assurance (QA) within the ICH-GCP environment
  • Interest / knowledge of electronic tools used in clinical trials (e.g., eTMF, ePRO, eSource)
  • Reliable, conscientious, agile/flexible, open-minded
  • Good risk analysis and problem-solving skills
  • Good negotiation skills 
  • Good writing, verbal and listening skills
  • Ability to work as a team player and independently
  • Experience and/or willingness to work in international cross-cultural relations

 

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

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