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

Location Switzerland
Discipline: Quality Assurance
Job type: Contract
Salary: £CHF 69.49 - 86.44
Contact name: Harry Henson

Contact email: harry.henson@rbwconsulting.com
Contact phone: +44 (0)1293 364 092
Job ref: 31889B2
Published: 10 days ago
Duration: 12 month contract
Expiry date: 03 Jul 2024 10:59
Startdate: ASAP

​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.