Skip to main content

This job has expired

Senior Clinical Quality Assurance Manager - 12 month contract - Allschwil based

Employer
RBW Consulting
Location
Switzerland
Salary
CHF 69.49 - 86.44
Start date
3 Jun 2024
Closing date
3 Jul 2024

Job Details

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.

Company

Learn more about this company

Visit this company’s hub to learn about their values, culture, and latest jobs.

Visit employer hub

Learn more about this company

Visit this company’s hub to learn about their values, culture, and latest jobs.

Visit employer hub

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert